510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912919Substantially Equivalent

Mentor Infusion Line

Mentor, Goleta CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912919 is the FDA 510(k) clearance record for MENTOR INFUSION LINE, a class II device, cleared for Mentor Corp. on under FDA product code KNY (Accessories, Catheter, G-U). FDA records list 65 510(k) clearances for Mentor Corp., from to . As of , FDA records show no recalls naming K912919.

Clearance record

Decision date
Received
(163 days to decision)
Product code
KNY Accessories, Catheter, G-U
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Mentor Corp. 600 Pine Ave., Goleta CA
510(k) summary
Statement
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