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2M8101 Heated Liquid Level Controller

by Travenol Laboratories, S.A.

510(k) K802144

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK802144 Date26 Sep 1980ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BTT
Device Class
Class II
Regulation
21 CFR Part 868.5450
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The 2M8101 Heated Liquid Level Controller is a respiratory gas humidifier designed for direct patient interface. It functions to regulate the level of heated liquid within the system to maintain appropriate humidification for respiratory therapy.

This device is manufactured by Travenol Laboratories, S.A. and has received FDA 510(k) clearance under the regulation number 868.5450. It is categorized under the anesthesiology advisory committee and is identified by the product code BTT.

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