Cleared Traditional

Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)

K241268 · Exceleron Medical · Anesthesiology

Aug 2024

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K241268 is an FDA 510(k) clearance for the Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS), a Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer (Class II — Special Controls, product code BZE), submitted by Exceleron Medical (St. Paul, US). The FDA issued a Cleared decision on August 2, 2024, 88 days after receiving the submission on May 6, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5270.

Submission Details

510(k) Number	K241268 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 2024
Decision Date	August 02, 2024
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	BZE — Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5270