510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K915171Substantially Equivalent

Lopez Valve Tm II

Abbott Medical, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915171 is the FDA 510(k) clearance record for LOPEZ VALVE TM II, a class II device, cleared for Icu Medical, Inc. on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K915171.

Clearance record

Decision date
Received
(84 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Icu Medical, Inc. 142 Technology Dr., Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code KNT

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