Penguin In-Line Warmer— 510(k) K150484

Substantially Equivalent

Creche Innovations

FDA 510(k) clearance K150484 for Penguin In-Line Warmer, Substantially Equivalent on 2015-07-09. Applicant: Creche Innovations.

Clearance details

Applicant: Creche Innovations
Product code: Code LGZ
Advisory panel: General Hospital
Date received: 2015-02-24
Decision date: 2015-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stilwell, KS, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LGZ

product code LGZ

Death: 16
Malfunction: 5,916
Other: 1
Total: 5,933

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.