FMLClass I

Chair, Blood Donor

21 CFR 880.6140 / General Hospital

FML is the FDA product code for Chair, Blood Donor, a class I device type, regulated under 21 CFR 880.6140. As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 1984-09-20, and no recalls.

Classification record

Product code: FML
Device name: Chair, Blood Donor
Regulation: 21 CFR 880.6140
Device class: Class I
Review panel: General Hospital
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code FML

By decision year

2 clearances under product code FML with a decision year between 1978 and 1984, 1978 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code FML by decision year
Year	Clearances
1978	1
1984	1

Applicants with the most clearances

Product code FML

Applicants holding the most 510(k) clearances under product code FML
Applicant	Clearances
Tillotson Rubber Co., Inc.	1
Ulster Scientific, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order

Recent clearances

Product code FML

Recent recalls

Product code FML

FDA records show no recalls under product code FML.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)