FPYClass I

Sheet, Burn

21 CFR 880.5180 / General Hospital

FPY is the FDA product code for Sheet, Burn, a class I device type, regulated under 21 CFR 880.5180. As of 2026-09-10, FDA records hold 17 510(k) clearances under this code, the most recent dated 1994-01-21, and one recall.

Classification record

Product code: FPY
Device name: Sheet, Burn
Regulation: 21 CFR 880.5180
Device class: Class I
Review panel: General Hospital
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 17
Ingested recalls: 1

Clearances, product code FPY

By decision year

17 clearances under product code FPY with a decision year between 1976 and 1994, 1990 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code FPY by decision year
Year	Clearances
1976	2
1978	1
1979	2
1980	1
1982	1
1984	1
1985	1
1987	1
1990	3
1993	3
1994	1

Applicants with the most clearances

Product code FPY

Applicants holding the most 510(k) clearances under product code FPY
Applicant	Clearances
Pilgrim Medical Services	3
American Medical Disposable, Inc.	2
Levtrade Intl. (Pty), Ltd.	2
Acme United Corp.	1
American Convertors Div., American Pharmaseal	1
American Safety	1
Consolidated Products & Services, Inc.	1
Gam Industries, Inc.	1
Reed Products, Inc.	1
The Kendal Co.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 54 companies shown, in name order