510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900031Substantially Equivalent

Modified Pediatric Silicone Foley Catheters

Porges Corp., Gary IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900031 is the FDA 510(k) clearance record for MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS, a class II device, cleared for Porges Corp. on under FDA product code KNY (Accessories, Catheter, G-U). FDA records list 22 510(k) clearances for Porges Corp., from to . As of , FDA records show no recalls naming K900031.

Clearance record

Decision date
Received
(61 days to decision)
Product code
KNY Accessories, Catheter, G-U
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Porges Corp. 5700 W. 23rd Ave., Gary IN
Third party review
No

Clearances, product code KNY

Trailing 12 months
1 clearance under product code KNY in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260