510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K854443Substantially Equivalent

O'neil Urinary Catheter Introducer

Pennine Medical, Ltd., Stoughton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854443 is the FDA 510(k) clearance record for O'NEIL URINARY CATHETER INTRODUCER, a class II device, cleared for Pennine Medical , Ltd. on under FDA product code KOD (Catheter, Urological). FDA records list 8 510(k) clearances for Pennine Medical , Ltd., from to . As of , FDA records show no recalls naming K854443.

Clearance record

Decision date
Received
(64 days to decision)
Product code
KOD Catheter, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Pennine Medical , Ltd. P.O. Box 648, Stoughton MA
Third party review
No

Clearances, product code KOD

Trailing 12 months
1 clearance under product code KOD in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KOD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260