510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921054Substantially Equivalent

Kendall Mod. Pediatric Ultramer Polyurethane Cath.

Kendall Healthcare Products Co. Div.Of Tyco Health, Mansfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921054 is the FDA 510(k) clearance record for KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH., a class II device, cleared for Kendall Healthcare Products Co. Div.Of Tyco Health on under FDA product code KOD (Catheter, Urological). FDA records list 66 510(k) clearances for Kendall Healthcare Products Co. Div.Of Tyco Health, from to . As of , FDA records show no recalls naming K921054.

Clearance record

Decision date
Received
(202 days to decision)
Product code
KOD Catheter, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Kendall Healthcare Products Co. Div.Of Tyco Health 15 Hampshire St., Mansfield MA
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