510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951597Substantially Equivalent

Urinary Drainage Bag

Key Medical Services, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951597 is the FDA 510(k) clearance record for URINARY DRAINAGE BAG, a class I device, cleared for Key Medical Services, Inc. on under FDA product code EYZ (System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile). FDA records list 2 510(k) clearances for Key Medical Services, Inc., from to . As of , FDA records show no recalls naming K951597.

Clearance record

Decision date
Received
(119 days to decision)
Product code
EYZ System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
Regulation
21 CFR 876.5250
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Key Medical Services, Inc. 5901 N. Milwaukee Ave., Chicago IL
510(k) summary
Summary
Third party review
No

Clearances, product code EYZ

Trailing 12 months

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

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