510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921490Unknown

Dressing Change Tray Decubitus Ulcer/sterile-Disp

Trinity Laboratories, Inc., Salisbury MD / Traditional, Unknown
FDA source (opens on fda.gov)

K921490 is the FDA 510(k) clearance record for DRESSING CHANGE TRAY DECUBITUS ULCER/STERILE-DISP, a class II device, cleared for Trinity Laboratories, Inc. on under FDA product code FRG (Wrap, Sterilization). FDA records list 44 510(k) clearances for Trinity Laboratories, Inc., from to . As of , FDA records show no recalls naming K921490.

Clearance record

Decision date
Received
(189 days to decision)
Product code
FRG Wrap, Sterilization
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Trinity Laboratories, Inc. 201 Kiley Dr., Salisbury MD
510(k) summary
Statement
Third party review
No

Clearances, product code FRG

Trailing 12 months
5 clearances under product code FRG in the twelve months to October 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FRG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20262
June 20260
July 20261
August 20260
September 20260
October 20260