510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911258Substantially Equivalent

Kendall Pediatric Urine Meter

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

K911258 is the FDA 510(k) clearance record for KENDALL PEDIATRIC URINE METER, a class II device, cleared for Kendall Healthcare Products Co. Div.Of Tyco Health on under FDA product code EXR (Urinometer, Mechanical). 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 K911258.

Clearance record

Decision date
Received
(34 days to decision)
Product code
EXR Urinometer, Mechanical
Regulation
21 CFR 876.1800
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Kendall Healthcare Products Co. Div.Of Tyco Health 15 Hampshire St., Mansfield MA
Third party review
No

Clearances, product code EXR

Trailing 12 months

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

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