510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920846Unknown

Central Venous Catheter, Dressing Change Kit, Ster

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

K920846 is the FDA 510(k) clearance record for CENTRAL VENOUS CATHETER, DRESSING CHANGE KIT, STER, a class II device, cleared for Trinity Laboratories, Inc. on under FDA product code FXX (Mask, Surgical). FDA records list 44 510(k) clearances for Trinity Laboratories, Inc., from to . As of , FDA records show no recalls naming K920846.

Clearance record

Decision date
Received
(189 days to decision)
Product code
FXX Mask, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Trinity Laboratories, Inc. 201 Kiley Dr., Salisbury MD
510(k) summary
Statement
Third party review
No

Clearances, product code FXX

Trailing 12 months
8 clearances under product code FXX in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FXX, trailing twelve months
MonthClearances
November 20251
December 20252
January 20262
February 20261
March 20262
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260