510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951443Substantially Equivalent

Standard Foley System Pak

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

K951443 is the FDA 510(k) clearance record for STANDARD FOLEY SYSTEM PAK, a class II device, cleared for Trinity Laboratories, Inc. on under FDA product code FCN (Urinary Drainage Collection Kit, For Indwelling Catheter). FDA records list 44 510(k) clearances for Trinity Laboratories, Inc., from to . As of , FDA records show no recalls naming K951443.

Clearance record

Decision date
Received
(78 days to decision)
Product code
FCN Urinary Drainage Collection Kit, For Indwelling Catheter
Regulation
21 CFR 876.5250
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Trinity Laboratories, Inc. 201 Kelly Dr., Salisbury MD
510(k) summary
Statement
Third party review
No

Clearances, product code FCN

Trailing 12 months

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

FDA records show no clearances under product code FCN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FCN, 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