FDA product code FML: Chair, Blood Donor
FML is the FDA product code for chair, blood donor. It is a Class I device, regulated under 21 CFR 880.6140 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under FML, from 2 different applicants. The average 510(k) review took 45 days (median 45).
Classification
| Field | Value |
|---|---|
| Device name | Chair, Blood Donor |
| Device class | Class I |
| Regulation | 21 CFR 880.6140 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every FML clearance
Top FML applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ulster Scientific, Inc. | 1 | 1984-09-20 |
| Tillotson Rubber Co., Inc. | 1 | 1978-02-21 |
Most recent FML clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842517 | Ulster Scientific, Inc. | UNILET LANCET | 1984-09-20 | 72 |
| K780181 | Tillotson Rubber Co., Inc. | GLOVES, FLOOR | 1978-02-21 | 18 |
Recalls for FML devices
openFDA lists no recalls for product code FML.
Frequently asked questions
What is FDA product code FML?
FML is the FDA product code for chair, blood donor. It is a Class I device, regulated under 21 CFR 880.6140 and reviewed by the General Hospital panel.
What device class is FML?
Class I, regulation 21 CFR 880.6140. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FML?
Across 2 cleared submissions the average was 45 days from receipt to decision (median 45).
Which companies have the most FML clearances?
Ulster Scientific, Inc. (1); Tillotson Rubber Co., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FML
- Run a recall and safety report across every FML manufacturer
- Watch product code FML for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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