Medline ComfortTemp Patient Warming System— 510(k) K231211

Substantially Equivalent

Medline Industries, LP

FDA 510(k) clearance K231211 for Medline ComfortTemp Patient Warming System, Substantially Equivalent on 2023-12-01. Applicant: Medline Industries, LP.

Clearance details

Applicant: Medline Industries, LP
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2023-04-28
Decision date: 2023-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northfield, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

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.