510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896581Substantially Equivalent

Pediatric Drain Bag

Laytech Medical Co., Arlington Heights IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896581 is the FDA 510(k) clearance record for PEDIATRIC DRAIN BAG, a class II device, cleared for Laytech Medical Co. on under FDA product code FFH (Collector, Urine, Pediatric, For Indwelling Catheter). FDA records list 2 510(k) clearances for Laytech Medical Co., from to . As of , FDA records show no recalls naming K896581.

Clearance record

Decision date
Received
(75 days to decision)
Product code
FFH Collector, Urine, Pediatric, For Indwelling Catheter
Regulation
21 CFR 876.5250
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Laytech Medical Co. 816 Nichols, Arlington Heights IL
Third party review
No

Clearances, product code FFH

Trailing 12 months

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

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