Healthdyne Impluse Ventilator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K853300 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Oxygen Concentrator, Model Bx-5000

  Class II

  FDA 510(k) K854374 Active Cleared 3 Jan 1986

• Healthdyne Event Recorder System

  Class II

  FDA 510(k) K860254 Active Cleared 30 Jan 1986

• Healthdyne Rate Meter

  Class II

  FDA 510(k) K874814 Active Cleared 11 Feb 1988

• Oxygen/Pulse Monitor

  Class II

  FDA 510(k) K875031 Active Cleared 12 Feb 1988

• Healthdyne's Apnea/Heart Monitor, Model 900S

  Class II

  FDA 510(k) K892006 Active Cleared 23 May 1989

• Ventilator, Infant Model 100

  Class II

  FDA 510(k) K781926 Active Cleared 21 Dec 1978

See all devices from Healthdyne, Inc. →

• What is the Healthdyne Impluse Ventilator used for?

  The Healthdyne Impluse Ventilator is a continuous ventilator designed to provide ventilatory assistance in clinical settings. It is a Class II medical device intended for facility use to support patients who require mechanical ventilation.

• Is the Healthdyne Impluse Ventilator single-use or reusable?

  The device data does not specify whether the Healthdyne Impluse Ventilator is single-use or reusable. This information would need to be obtained directly from the manufacturer or product documentation.

• What regulatory approvals does the Healthdyne Impluse Ventilator have?

  The Healthdyne Impluse Ventilator received FDA 510(k) clearance in 1985. It is classified as a Class II medical device and was determined to be substantially equivalent to other devices on the market.

• What are the specifications of the Healthdyne Impluse Ventilator?

  The Healthdyne Impluse Ventilator is a continuous ventilator for facility use. Specific technical specifications beyond its classification as a Class II device and its intended use are not provided in the available data.