Written and maintained by CASRAI Editorial Board
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This page describes products and general use; it is not medical advice.
Short answer: blood pressure monitors are not “FDA approved” in the strict regulatory sense. Noninvasive blood pressure measurement systems are Class II devices under 21 CFR 870.1130, and they reach the U.S. market through a 510(k) premarket notification, which FDA answers with a clearance order, not a premarket approval. Searchers use “FDA approved”, “FDA cleared” and “FDA registered” loosely; this page separates them and shows where to check a specific model.
Who uses this: clinic staff and others checking a monitor’s regulatory status, and students learning how device oversight works. It does not list or rank products.
Is there an FDA-approved blood pressure monitor?
Not under the strict meaning of “approved”. FDA’s regulation for this device type, 21 CFR 870.1130, defines a noninvasive blood pressure measurement system as a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived, using transducers placed on the surface of the body. The same regulation classifies it as Class II (performance standards). Source: the Cornell LII copy of the CFR, checked 2026-10-30.
FDA’s 510(k) page explains that a 510(k) is a premarket submission showing that a device is as safe and effective as a legally marketed predicate device, and that the outcome is an order, in the form of a letter, finding the device substantially equivalent. The page says 510(k) applies to devices for which a Premarket Approval (PMA) application is not required (FDA, checked 2026-10-30). In plain terms, a monitor that is “FDA cleared” has a 510(k) order; “FDA approved” describes the separate PMA pathway, which is not the route for this device type.
FDA cleared vs FDA approved
The two words name different FDA actions. The pathway difference is summarised in CASRAI’s FDA clearance vs approval and 510(k) vs PMA comparisons, and the 510(k) mechanics are in the 510(k) premarket notification guide.
- Cleared: FDA found the device substantially equivalent to a predicate through the 510(k) route. Substantial equivalence includes having the same intended use as the predicate.
- Approved: the term for a PMA decision, used for devices where a PMA is required. It is not what a Class II blood pressure monitor receives.
Manufacturers and retailers often write “FDA approved” on packaging and listings anyway. A claim on a box is not a regulatory record; the record is the 510(k) entry described below.
What a clearance record shows
Using FDA’s openFDA device classification and 510(k) interfaces (checked 2026-10-30), the noninvasive blood pressure measurement regulation maps to these identifiers:
- Regulation number: 870.1130, Class II, specialty Cardiovascular.
- Product code DXN: “System, Measurement, Blood-Pressure, Non-Invasive”, eligible for third-party 510(k) review, submission type 510(k).
- Product code QYF: “Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)”, also Class II under 870.1130.
- Record count: openFDA returned 1,226 510(k) records for product code DXN as of 2026-10-30.
An individual record carries a K number, a device name, a decision (for example “Substantially Equivalent”) and a clearance type such as Traditional or Special. Two recent DXN records, decided in 2026, were titled “Electronic Blood Pressure Monitor” (decided 2026-10-01, Traditional) and “Upper Arm Blood pressure monitor” (decided 2026-09-10, Special). They are shown only to illustrate what a record looks like, not as recommendations.
How to check whether a specific monitor is FDA cleared
- Find the manufacturer’s model name and any K number printed in the manual or on the manufacturer’s regulatory page.
- Search FDA’s 510(k) database by K number, applicant or product code DXN.
- Open the record and confirm the device name, the decision and the applicant match the product in front of you.
A record belongs to a specific device and applicant. A similar-looking monitor sold under another brand name is not covered unless it appears in its own record.
Claim ladder: what each claim tells you
| Claim you see | What it tells you | Where it is checked |
|---|---|---|
| “FDA approved” | Strictly, a PMA decision. Not the pathway for a Class II blood pressure monitor. | FDA 510(k) page, 21 CFR 870.1130 |
| “FDA cleared” | A 510(k) order finding the device substantially equivalent to a predicate, including the same intended use. | FDA 510(k) database |
| Class II, product code DXN | The regulatory classification and product code for noninvasive blood pressure measurement systems. | 21 CFR 870.1130, openFDA classification |
| “Validated for clinical accuracy” | A separate check. The U.S. Blood Pressure Validated Device Listing, launched in 2020, lists devices validated for clinical accuracy and tested against the gold standard, reviewed by an independent expert panel. | AMA article on the validated device listing |
The AMA article (published 2023-02-07, checked 2026-10-30) says an expert panel of 13 physicians reviews manufacturers’ submitted testing data against criteria for clinical accuracy. Validation is its own review, separate from FDA clearance, so clearance and validation are two different questions.
Wrist and upper-arm monitors
The 870.1130 definition covers devices that derive pressures from transducers on the surface of the body and does not distinguish cuff location, so wrist and upper-arm monitors are both described by the same regulation. Each model still needs its own clearance record. For cuff fit and the general differences between sites, see the blood pressure cuff guide; for manual devices, see the aneroid sphygmomanometer guide. Related equipment is grouped under diagnostic and monitoring equipment.
FDA-approved blood pressure monitor list: why there is no single list
No single FDA list of “approved” monitors exists, because the relevant FDA records are individual 510(k) entries searchable by product code. The closest equivalents are the 510(k) database filtered to DXN and, for accuracy validation, the separate Validated Device Listing. For an overview of choosing monitoring equipment more broadly, see choosing diagnostic and patient monitoring equipment.
Common mistakes
- Treating “FDA approved” on a package or listing as proof; check the 510(k) record instead.
- Assuming clearance and clinical-accuracy validation are the same check; the AMA describes the validated device listing as a separate review.
- Matching on brand name rather than model, K number and applicant.
- Reading a clearance as a statement about one individual’s health.
FAQ
Is “FDA cleared” the same as “FDA approved” for a blood pressure monitor?
No. Cleared means a 510(k) order finding substantial equivalence to a predicate; approved refers to a PMA, which is not required for this Class II device type.
What is the product code for a noninvasive blood pressure monitor?
DXN, “System, Measurement, Blood-Pressure, Non-Invasive”, under 21 CFR 870.1130 (openFDA, checked 2026-10-30). A neonatal ICU continuous monitor uses QYF under the same regulation.
Where can I find a blood pressure monitor FDA list?
Use FDA’s 510(k) database and search by K number or product code DXN. There is no single “approved” list.
How do I check an FDA cleared wrist blood pressure monitor?
The 870.1130 definition does not distinguish cuff location, and each model needs its own 510(k) record, so check the specific wrist model rather than the category.
Does FDA clearance mean the monitor is validated for accuracy?
Not on its own. The AMA describes the Validated Device Listing as a separate, independent expert-panel review of clinical accuracy, distinct from FDA clearance.
Sources
- FDA, Premarket Notification 510(k), checked 2026-10-30.
- 21 CFR 870.1130, Noninvasive blood pressure measurement system, via Cornell LII, checked 2026-10-30.
- openFDA device classification and 510(k) endpoints, checked 2026-10-30.
- FDA, 510(k) database, checked 2026-10-30.
- American Medical Association, Why a validated device listing is important for BP control, 2023-02-07, checked 2026-10-30.
