Lifecare CPAP-100

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K912224 ↗

FDA Product Code

BZD

Device Class

Class II

Regulation

21 CFR Part 868.5905

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Nev-10 Negative Pressure Ventilator

  Class II

  FDA 510(k) K910947 Active Cleared 3 Jun 1991

• 6-415 Filter, Element, 170-C

  Class II

  FDA 510(k) K802925 Active Cleared 19 Dec 1980

• Portable Lifecare Ventilator Plv-100

  Class II

  FDA 510(k) K832467 Active Cleared 20 Oct 1983

• Respiraotr, CAM-10 RBL

  Class II

  FDA 510(k) K790605 Active Cleared 3 Jul 1979

• Cam-10 Respiratory Hose Assemblies

  Class I

  FDA 510(k) K801859 Active Cleared 9 Sep 1980

• Lifecare Remote Alarm #34-001

  Class II

  FDA 510(k) K862212 Active Cleared 23 Jun 1986

See all devices from Lifecare Services, Inc. →

• What is the LIFECARE CPAP-100 used for?

  The LIFECARE CPAP-100 is a ventilator device designed to provide respiratory support to patients by delivering continuous positive airway pressure. It is specifically intended for use in anesthesiology settings.

• What is the regulatory classification of the LIFECARE CPAP-100?

  The LIFECARE CPAP-100 is classified as a Class II medical device and received FDA 510(k) clearance on September 23, 1991, with product code BZD. It was determined to be substantially equivalent to other devices in its class.

• Is the LIFECARE CPAP-100 reusable or single-use?

  The device data does not specify whether the LIFECARE CPAP-100 is designed for single-use or multiple uses. For specific information regarding reusability, please consult the manufacturer's instructions or contact Lifecare Services, Inc. directly.

• What are the available sizes or models of the LIFECARE CPAP-100?

  The device data does not indicate multiple sizes or models for the LIFECARE CPAP-100. The information provided refers to a single device model, the LIFECARE CPAP-100, manufactured by Lifecare Services, Inc.