510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K870165Substantially Equivalent

Foley Catheter

Acorn Medical Products, Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870165 is the FDA 510(k) clearance record for FOLEY CATHETER, a class II device, cleared for Acorn Medical Products on under FDA product code KOD (Catheter, Urological). FDA records list one 510(k) clearance for Acorn Medical Products. As of , FDA records show no recalls naming K870165.

Clearance record

Decision date
Received
(93 days to decision)
Product code
KOD Catheter, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Acorn Medical Products 1036 Cowper St., Palo Alto CA
Third party review
No

Clearances, product code KOD

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