Nebulizer System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K922623 ↗

FDA Product Code

BTI

Device Class

Class II

Regulation

21 CFR Part 868.6250

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Healthdyne Impluse Ventilator

  Class II

  FDA 510(k) K853300 Active Cleared 15 Aug 1985

• 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

See all devices from Healthdyne, Inc. →

• What is the NEBULIZER SYSTEM used for?

  The NEBULIZER SYSTEM is a portable air compressor device designed to deliver medication in the form of a mist that is inhaled into the lungs, specifically intended for use in anesthesiology settings as stated in the device description.

• Is the NEBULIZER SYSTEM reusable or single-use, and does it require sterilization?

  The device is supplied as a reusable system and requires no sterilization between uses, as explicitly noted in the description, meaning it can be used multiple times following manufacturer guidelines without reprocessing for sterility.

• What are the storage requirements for the NEBULIZER SYSTEM?

  Storage should follow manufacturer guidelines, as indicated in the device description, though specific temperature, humidity, or environmental conditions are not detailed in the provided data.

• What regulatory pathway was used for the NEBULIZER SYSTEM, and what is its classification?

  The NEBULIZER SYSTEM received FDA 510(k) clearance under product code BTI and regulation number 868.6250, and is classified as a Class II medical device based on substantial equivalence to a legally marketed device.