Cleared Traditional

Celsi Warmer

K242964 · Hadleigh Health Technologies · Cardiovascular

Jun 2025

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K242964 is an FDA 510(k) clearance for the Celsi Warmer, a System, Thermal Regulating (Class II — Special Controls, product code DWJ), submitted by Hadleigh Health Technologies (Sausalito, US). The FDA issued a Cleared decision on June 20, 2025, 267 days after receiving the submission on September 26, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K242964 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2024
Decision Date	June 20, 2025
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DWJ — System, Thermal Regulating
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5900
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).