Celsi Warmer— 510(k) K242964

Name: FDA 510(k) clearance K242964
Creator: U.S. Food and Drug Administration
Published: 2025-06-20

Substantially Equivalent

Hadleigh Health Technologies

FDA 510(k) clearance K242964 for Celsi Warmer, Substantially Equivalent on 2025-06-20. Applicant: Hadleigh Health Technologies. Device class: 2.

Clearance details

Applicant: Hadleigh Health Technologies
Product code: Code DWJ
Device class: Class 2
Regulation: 21 CFR 870.5900
Advisory panel: Cardiovascular
Date received: 2024-09-26
Decision date: 2025-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sausalito, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWJ

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K262089 — Disposable Warming Blanket2026-08-21
K261437 — Mistral-Air® Warming System2026-08-07
K260278 — ThermAffyx(TM) Patient Safety System2026-07-08
K260903 — Hot Pink Pad Warming System2026-04-16
K252861 — Warming System2026-04-07

More clearances from Hadleigh Health Technologies

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K230298 — Celsi Monitor2023-08-16

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.