Skip to content

Life Pulse High Frequency Ventilator Model 203

by Bunnell, Inc. PMA

Active United States

PMA P850064

Overview

The Life Pulse High Frequency Ventilator Model 203 is a high-frequency ventilator designed to provide mechanical ventilation for patients requiring advanced respiratory support. It operates using high-frequency oscillatory ventilation (HFOV) principles, delivering rapid, small tidal volumes to improve gas exchange in critical care settings.

This device is intended for use in clinical environments such as operating rooms, intensive care units, and emergency departments. Supplied sterile and intended for single-use, it is regulated under FDA Premarket Approval (PMA) with PMA number P850064. The ventilator is classified as a Class III medical device and adheres to strict manufacturing and performance standards to ensure patient safety and efficacy.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP850064 Date30 Jun 1988ApprovedStatusActive

Coverage

1 jurisdiction

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

United States — FDA PMA Active

Recalls

4 recalls · FDA

    • Terminated Z-0514-2013 FDA Class I initiated 19 Nov 2012

    Customer complaints received indicate the heater wire insulation can melt, causing a short which creates sparking and smoke, in the circuit close to the humidifier cartridge. Bunnell is recalling all lots of circuits distributed between March 12, 2012 and November 30, 2012.

  • 2 recalls, same reason

    • Terminated Z-0902-2011 FDA Unclassified (pre-2012) initiated 25 Oct 2010
    • Terminated Z-0901-2011 FDA Unclassified (pre-2012) initiated 25 Oct 2010

    Product software coding error may compromise patient safety.

    • Terminated Z-0893-06 FDA Unclassified (pre-2012) initiated 4 Apr 2005

    Potential loss of air flow or change in cycling of the ventilator. Valve Drive Regulator Board may not function properly at elevated temperatures. The increase in temperature could cause a reduction of power, causing the solenoid in the valve to function sporadically.

Specification

PMA

Full name
Life Pulse High Frequency Ventilator
Trade Name
Model 203 Life Pulse High Frequency Ventilator
Generic Name
VENTILATOR, HIGH FREQUENCY
PMA Number
FDA Product Code
LSZ
Device Class
Class III
Advisory Committee
Anesthesiology
FDA Decision
APPR Approved

Questions

  • What types of clinical settings is the Life Pulse High Frequency Ventilator intended for use in?

    The Life Pulse High Frequency Ventilator (Model 203) is specifically designed for advanced respiratory support in controlled clinical environments such as operating rooms, intensive care units (ICUs), and emergency departments where high-frequency oscillatory ventilation (HFOV) may be required.

  • Is the Life Pulse High Frequency Ventilator reusable or single-use, and how is it supplied?

    The Life Pulse High Frequency Ventilator is supplied sterile and intended for **single-use only**. This design ensures patient safety by eliminating the risk of cross-contamination between uses, which is critical in critical care settings.

  • What regulatory pathway does the Life Pulse High Frequency Ventilator follow, and what does that mean for its use?

    The ventilator follows the **FDA Premarket Approval (PMA) pathway**, with PMA number **P850064**, confirming it meets stringent Class III medical device standards. This approval ensures compliance with rigorous manufacturing, performance, and safety requirements before clinical use.

  • How does the Life Pulse High Frequency Ventilator differ from standard ventilators in terms of ventilation technique?

    Unlike traditional ventilators, the Life Pulse High Frequency Ventilator uses **high-frequency oscillatory ventilation (HFOV)**, delivering rapid, small tidal volumes to enhance gas exchange. This technique is particularly beneficial for patients with severe respiratory distress or conditions requiring precise, high-frequency airflow control.

  • What advisory committee was involved in the review process for this ventilator, and what does that indicate about its clinical focus?

    The ventilator was reviewed by the **Anesthesiology (AN) Advisory Committee**, which suggests its primary clinical focus aligns with anesthesia-related respiratory support. This committee provides expert guidance on devices used during surgical procedures and critical care scenarios where anesthesia is administered.