510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922051Unknown

Kit Pak's Flushing Kit

Kit Pak, Inc., Elk Grove Village IL / Traditional, Unknown
FDA source (opens on fda.gov)

K922051 is the FDA 510(k) clearance record for KIT PAK'S FLUSHING KIT, a class II device, cleared for Kit Pak, Inc. on under FDA product code KOD (Catheter, Urological). FDA records list 13 510(k) clearances for Kit Pak, Inc., from to . As of , FDA records show no recalls naming K922051.

Clearance record

Decision date
Received
(412 days to decision)
Product code
KOD Catheter, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Kit Pak, Inc. 825 Chase Ave., Elk Grove Village IL
510(k) summary
Statement
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