510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780190Substantially Equivalent

Catheter Strap & Ruinary Bay Holder

Baka Manufacturing Co., Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780190 is the FDA 510(k) clearance record for CATHETER STRAP & RUINARY BAY HOLDER, a class I device, cleared for Baka Manufacturing Co., Inc. on under FDA product code FAQ (Bag, Urine Collection, Leg, For External Use, Sterile). FDA records list 2 510(k) clearances for Baka Manufacturing Co., Inc., from to . As of , FDA records show no recalls naming K780190.

Clearance record

Decision date
Received
(15 days to decision)
Product code
FAQ Bag, Urine Collection, Leg, For External Use, Sterile
Regulation
21 CFR 876.5250
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Baka Manufacturing Co., Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FAQ

Trailing 12 months

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

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