510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900442Substantially Equivalent

Burns Casualty Sheet Burn Roll

Pilgrim Medical Services, England Hr2 6sx, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900442 is the FDA 510(k) clearance record for BURNS CASUALTY SHEET BURN ROLL, a class I device, cleared for Pilgrim Medical Services on under FDA product code FPY (Sheet, Burn). FDA records list 3 510(k) clearances for Pilgrim Medical Services. As of , FDA records show no recalls naming K900442.

Clearance record

Decision date
Received
(154 days to decision)
Product code
FPY Sheet, Burn
Regulation
21 CFR 880.5180
Device class
Class I
Review panel
General Hospital
Applicant
Pilgrim Medical Services The Old Coach House, England Hr2 6sx, GB
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