510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K871740Substantially Equivalent

Lyosheet Surgical Sheet for Burns

Acme United Corp., Fairfield CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871740 is the FDA 510(k) clearance record for LYOSHEET SURGICAL SHEET FOR BURNS, a class I device, cleared for Acme United Corp. on under FDA product code FPY (Sheet, Burn). FDA records list 27 510(k) clearances for Acme United Corp., from to . As of , FDA records show no recalls naming K871740.

Clearance record

Decision date
Received
(35 days to decision)
Product code
FPY Sheet, Burn
Regulation
21 CFR 880.5180
Device class
Class I
Review panel
General Hospital
Applicant
Acme United Corp. 425 Post Rd., Fairfield CT
Third party review
No

Clearances, product code FPY

Trailing 12 months

FDA records hold no clearances under product code FPY in the trailing twelve months.

FDA records show no clearances under product code FPY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FPY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260