510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K935557Substantially Equivalent

Urinary Drainage Bag

Puritas Health Care, Inc., New Milford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935557 is the FDA 510(k) clearance record for URINARY DRAINAGE BAG, a class II device, cleared for Puritas Health Care, Inc. on under FDA product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter). FDA records list 24 510(k) clearances for Puritas Health Care, Inc., from to . As of , FDA records show no recalls naming K935557.

Clearance record

Decision date
Received
(110 days to decision)
Product code
KNX Collector, Urine, (And Accessories) For Indwelling Catheter
Regulation
21 CFR 876.5250
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Puritas Health Care, Inc. 219 Kent Rd.,, New Milford CT
510(k) summary
Statement
Third party review
No

Clearances, product code KNX

Trailing 12 months

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

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