Written and maintained by CASRAI Editorial Board
Last updated
This page describes products and general use; it is not medical advice.
A catheter stylet is a wire that runs through a catheter or cannula to make it stiff. In the United States it is a Class II device under 21 CFR 870.1380, with FDA product code DRB. Clinic staff, buyers and students looking up the term can use this page to separate the stylet from a guide wire and to read a product record correctly.
What is a catheter stylet?
The federal regulation gives the definition in one sentence: “A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.” The same section classifies the device as Class II (performance standards) (21 CFR 870.1380, eCFR, checked 2026-10-31).
Who uses it: clinicians who work with catheters and cannulae, and the staff who stock and identify those supplies. This page does not cover how to use a stylet on a patient.
How it is built and what the FDA record says
The regulation describes a wire and nothing more, so it names no materials, tip shapes or lengths. The FDA Product Classification database entry for product code DRB, “Stylet, catheter” (regulation 870.1380, device class 2, review panel Cardiovascular), adds these flags, according to openFDA data last updated 2026-10-19:
- Not marked life-sustaining or life-supporting.
- Not exempt from good manufacturing practice (GMP) requirements.
- Eligible for 510(k) third-party review and for summary malfunction reporting.
- Submission type: 510(k).
What FDA device records show about stylets sold in the US
The FDA’s AccessGUDID data (queried through openFDA, data last updated 2026-10-01) holds 281 device records listed under product code DRB. Of those, 279 are labeled single-use and 280 are labeled sterile. A buyer or student should therefore expect a stylet to arrive as a sterile, single-use item, but should confirm this on the specific product’s label and instructions for use.
| Item | Value in FDA records | Source |
|---|---|---|
| Regulation | 21 CFR 870.1380 | eCFR, checked 2026-10-31 |
| Classification | Class II | eCFR; FDA product classification, code DRB |
| Review panel | Cardiovascular | FDA product classification, code DRB |
| GUDID records under DRB | 281, of which 279 single-use and 280 sterile | AccessGUDID via openFDA, data updated 2026-10-01 |
Catheter stylet vs guide wire and other look-alikes
The most common mix-up is between a stylet and a catheter guide wire. The regulations define them differently.
| Device | Regulatory definition | Class |
|---|---|---|
| Catheter stylet (21 CFR 870.1380) | A wire that is run through a catheter or cannula to render it stiff. | Class II (performance standards) |
| Catheter guide wire (21 CFR 870.1330) | A coiled wire designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. | Class II (special controls) |
In the regulations, then, a stylet stiffens a catheter or cannula, while a guide wire directs a catheter through a vessel. Related pages on this site cover products that share the word “stylet” or a similar job: the stylet for an endotracheal tube and the intubation bougie are airway devices, and the Council tip catheter is a urinary catheter with its own accessory stylet. For the catheter itself, see catheter lumen, and for a kit that contains a catheter, see the central line kit.
Sizes and where to check them
The regulation and the FDA classification record state no sizes, and this page gives none. Size, length, stiffness and compatibility are set by the manufacturer for each catheter model and appear on that product’s instructions for use and in its GUDID record. A GUDID record lists the model number, whether the item is sterile and single-use, its storage temperature range and its MRI safety labeling, which makes it a place to check a product’s labeling. Catheter categories are listed under IV catheters.
Safe use and handling basics
- Follow the manufacturer’s instructions for use for the specific catheter and stylet; the instructions govern use, not this page.
- Because the FDA records above show these items as sterile and single-use, do not assume a stylet can be re-sterilized or reused unless the product’s own labeling says so.
- Training, technique and any clinical decision belong to the treating clinician and the facility’s own policy.
Common mix-ups
- Calling a guide wire a stylet. The two have different regulations (870.1330 and 870.1380) and different defined purposes.
- Assuming an airway stylet and a catheter stylet are the same product. Check the product code and the device it is meant to accompany.
- Treating the regulation as a size or material specification. It defines the device type only.
FAQ
What is a catheter stylet?
It is a wire that is run through a catheter or cannula to render it stiff, as defined in 21 CFR 870.1380.
Is a catheter stylet the same as a guide wire?
No. A guide wire (21 CFR 870.1330) is a coiled wire designed to fit inside a percutaneous catheter for directing it through a blood vessel; a stylet is defined by stiffening the catheter or cannula.
Is a catheter stylet an FDA-regulated device?
Yes. It is a Class II device under product code DRB, with a 510(k) submission type, per the FDA Product Classification database.
Are catheter stylets single-use?
In AccessGUDID, 279 of 281 records under product code DRB are labeled single-use. The product’s own labeling is the deciding source.
Sources
- 21 CFR 870.1380, Catheter stylet: https://www.ecfr.gov/current/title-21/section-870.1380 (checked 2026-10-31).
- 21 CFR 870.1330, Catheter guide wire: https://www.ecfr.gov/current/title-21/section-870.1330 (checked 2026-10-31).
- FDA Product Classification, product code DRB: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=DRB, with the openFDA device classification API (data updated 2026-10-19), https://api.fda.gov/device/classification.json?search=product_code:DRB (checked 2026-10-31).
- FDA AccessGUDID via the openFDA device UDI API (data updated 2026-10-01), https://api.fda.gov/device/udi.json?search=product_codes.code:DRB (checked 2026-10-31).
