510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131154Substantially Equivalent

Enteralite Infinity Spike Enteral Delivery Set; Enteralite Infinity 500 Ml Bag Enteral Delivery Set;

Zevex, Inc., Salt Lake City UT / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131154 is the FDA 510(k) clearance record for ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET;, a class II device, cleared for Zevex, Inc. on under FDA product code LZH (Pump, Infusion, Enteral). FDA records list 5 510(k) clearances for Zevex, Inc., from to . As of , FDA records show no recalls naming K131154.

Clearance record

Decision date
Received
(294 days to decision)
Product code
LZH Pump, Infusion, Enteral
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Zevex, Inc. 4314 Zevex Park Ln.,, Salt Lake City UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LZH

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