Written and maintained by CASRAI Editorial Board
Last updated
This page describes products and general use; it is not medical advice.
A phlebotomy chair, also sold as a blood drawing chair, is a purpose-built seat with an adjustable arm rest that supports a person while blood is collected. This page is for clinic staff, lab and collection-site buyers, and students who need to know how FDA classifies the chair, what the build and size fields on manufacturer sheets mean, and the one safety limit manufacturers state plainly.
What a phlebotomy chair is
A phlebotomy chair is a stationary chair whose arm rest holds the forearm steady during a blood draw. In FDA’s device database the product is listed as "Chair, Blood Donor" (product code FML), a Class I device under 21 CFR 880.6140, "Medical chair and table". It is typically used in clinics, hospital outpatient labs and blood collection sites by phlebotomists, nurses and lab staff.
How FDA describes and classifies it
- 21 CFR 880.6140(a) describes a medical chair as a chair without wheels and not electrically powered which, through special shape or attachments (such as food trays or headrests) or features (such as a built-in raising and lowering mechanism or removable arms), is intended for use of blood donors, geriatric patients, or patients undergoing treatment or examination.
- Under 880.6140(b) it is Class I (general controls). It is exempt from 510(k) premarket notification, subject to the limitations in 21 CFR 880.9, and exempt from the quality management system regulation (part 820) except for requirements on records and complaint files under 820.35.
- FDA’s classification record for product code FML lists medical specialty General Hospital, not life-sustaining, not an implant, and eligible for summary malfunction reporting. openFDA states its data is unvalidated.
The regulation’s wording covers chairs that are not electrically powered and have no wheels. This page does not claim that power-recline or wheeled chairs are described by 880.6140.
How it is built
The regulation names the defining features (special shape, attachments, a raising and lowering mechanism, removable arms). Manufacturer sheets show how two specific models are built.
- Both Clinton Industries models described here use a 1-1/4 inch square all-welded tubular steel frame.
- The arm is a padded flip arm that is positioned in place during use and swings or flips out of the way for the person to get in and out. The bariatric model’s arm adjusts in height and depth.
- The bariatric model has 2 inch padding with vinyl upholstery and an elbow rest and drawer top in a cleanable surface (ClintonClean). The standard model has a one-piece plastic seat and adjustable foot levelers.
Types and variants
The table compares two real models from one manufacturer. It illustrates how a standard and a bariatric chair differ; the figures are those two models’ published specifications, not industry norms.
| Type | Model | Seat (W x D x H) | Overall size | Capacity (normal use) |
|---|---|---|---|---|
| Standard blood drawing chair with flip arm and drawer | Clinton blood drawing chair with ClintonClean flip arm and drawer | 18 in x 17 in x 20 in | 40 in W x 28 in D | 300 lb |
| Bariatric blood drawing chair | Clinton Lab X Series 66002B | 35 in x 21 in x 20 in | 53 in W x 29 in D x 36 in H | 700 lb (317.8 kg), combined load |
Sources: Clinton Industries 66002B specification sheet; distributor listing relaying the standard model’s manufacturer specifications (both checked 2026-10-30; links in the Sources section).
Sizes and specifications that matter
Manufacturer sheets state the same handful of fields, and these are the ones worth comparing between models:
- Seat width, depth and height, which set the space available to the person seated.
- Overall width and depth, which set the floor footprint. The standard model lists 40 in x 28 in; the bariatric 66002B lists 53 in x 29 in.
- Arm adjustment range. The standard model lists a 6 in arm adjustment and an arm height range of 27 to 33 in; the 66002B lists 6 in of arm adjustment.
- Weight capacity and the condition attached to it. Both sheets rate capacity under "normal use".
How to choose
FDA’s regulation defines the chair but does not set selection criteria. The practical comparison is the manufacturer’s own specification fields above: rated capacity, seat and overall dimensions, arm adjustment and the surface materials the maker names.
Safe use and handling basics
- Clinton’s specification sheet states: "Clinton Blood Drawing Chairs are not engineered to restrain a fainting or falling occupant. The chair’s occupant should NEVER be left unattended."
- Position the flip arm in place for use and flip it out of the way for exit, as the manufacturer describes.
- Stay within the rated capacity; the sheets rate it under normal use.
- Follow the manufacturer’s instructions for use and cleaning for the specific model. For the wider supplies a collection area needs, see the phlebotomy lab supply checklist.
Common mistakes
- Treating the chair as a restraint. The manufacturer says it is not engineered to hold a fainting or falling person.
- Leaving the occupant alone, which the same sheet says should never happen.
- Assuming every chair sold for blood collection falls under 880.6140. The regulation describes chairs without wheels and not electrically powered.
- Reading capacity as a limit for any condition; both sheets rate it under normal use.
FAQ
Is a phlebotomy chair a medical device?
Yes. FDA lists it as "Chair, Blood Donor" (product code FML), a Class I device under 21 CFR 880.6140. For the wider definition see what is a medical device.
Does a phlebotomy chair need FDA 510(k) clearance?
Not under 880.6140: the Class I device is exempt from 510(k) notification, subject to the limitations in 21 CFR 880.9.
Can a phlebotomy chair restrain a patient who faints?
No. One manufacturer states its chairs are not engineered to restrain a fainting or falling occupant and the occupant should never be left unattended.
How much weight can a blood drawing chair hold?
It depends on the model. The two Clinton models compared above are rated 300 lb and 700 lb under normal use.
Where else is the chair covered on CASRAI?
See the exam room furnishing checklist and the clinic startup equipment checklist. For the needle side of a draw, see butterfly vs straight needle venipuncture.
Sources
- 21 CFR 880.6140, Medical chair and table, Legal Information Institute copy, https://www.law.cornell.edu/cfr/text/21/880.6140 (checked 2026-10-30).
- openFDA device classification, product code FML, https://api.fda.gov/device/classification.json?search=product_code:FML (checked 2026-10-30).
- Clinton Industries, Lab X Series Model 66002B bariatric blood drawing chair specification sheet, https://cdn.shopify.com/s/files/1/0612/0223/5497/files/Clinton-66002B-Lab-X-Series-Bariatric-Blood-Drawing-Chair-with-Padded-Flip-Arm-and-Drawer-Spec-Sheet.pdf (checked 2026-10-30).
- Clinton blood drawing chair with ClintonClean flip arm and drawer, distributor listing relaying manufacturer specifications, https://www.diamedicalusa.com/Clinton-Blood-Drawing-Chair-with-ClintonClean-Flip-Arm-and-Drawer (checked 2026-10-30).
