510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853145Substantially Equivalent for Some Indications

Kendall Curity Burn Pad

The Kendal Co., Boston MA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K853145 is the FDA 510(k) clearance record for KENDALL CURITY BURN PAD, a class I device, cleared for The Kendal Co. on under FDA product code FPY (Sheet, Burn). FDA records list 63 510(k) clearances for The Kendal Co., from to . As of , FDA records show no recalls naming K853145.

Clearance record

Decision date
Received
(32 days to decision)
Product code
FPY Sheet, Burn
Regulation
21 CFR 880.5180
Device class
Class I
Review panel
General Hospital
Applicant
The Kendal Co. One Federal St., Boston MA
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