510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K150484Substantially Equivalent

Penguin In-Line Warmer

Creche Innovations, Stilwell KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150484 is the FDA 510(k) clearance record for Penguin In-Line Warmer, a class II device, cleared for Creche Innovations on under FDA product code LGZ (Warmer, Thermal, Infusion Fluid). FDA records list one 510(k) clearance for Creche Innovations. As of , FDA records show no recalls naming K150484.

Clearance record

Decision date
Received
(135 days to decision)
Product code
LGZ Warmer, Thermal, Infusion Fluid
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Creche Innovations 17745 Metcalf, Stilwell KS
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LGZ

Trailing 12 months
3 clearances under product code LGZ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LGZ, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260