510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K011340Substantially Equivalent

Lh 450 Enteral Feeding Bag Pump Set W/integrated Y-Port

Lh Medical Products, Inc., San Dimas CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011340 is the FDA 510(k) clearance record for LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT, a class II device, cleared for Lh Medical Products, Inc. on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list 3 510(k) clearances for Lh Medical Products, Inc. As of , FDA records show no recalls naming K011340.

Clearance record

Decision date
Received
(142 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Lh Medical Products, Inc. 301 E. Arrow Hwy., Suite 104, San Dimas CA
510(k) summary
Summary
Third party review
No

Clearances, product code KNT

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