Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: LifePulse® High Frequency Ventilator
• Generic Name: VENTILATOR, HIGH FREQUENCY
• Applicant: Bunnell, Inc.; 436 Lawndale Dr.; Salt Lake City, UT 84115
• PMA Number: P850064
• Supplement Number: S056
• Date Received: 04/09/2025
• Decision Date: 09/28/2026
• Product Code: LSZ
• Advisory Committee: Anesthesiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) 180-day supplement, which requested approval for an update to the Indications for Use (IFU). The approved updated IFU will read: “The LifePulse High Frequency Ventilator is indicated for treating pediatric patients (including neonates) who require temporary ventilatory support for acute respiratory failure. It is the responsibility of the clinician to determine the appropriate use of the LifePulse High Frequency Ventilator. The user needs to consider the respiratory status and the general state of health of the patient in order to optimally set ventilator settings for the patient’s condition(s).”