PMA P850064S056

Device: LifePulse® High Frequency Ventilator
Applicant: Bunnell, Inc.
PMA number: P850064
Supplement: S056
Product code: LSZ
Decision date: 2026-09-28
Classification: Anesthesiology
Generic name: VENTILATOR, HIGH FREQUENCY
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).”

Current openFDA PMA Record#

Device: LifePulse® High Frequency Ventilator
Applicant: Bunnell, Inc.
PMA number: P850064
Supplement: S056
Product code: LSZ
Generic name: VENTILATOR, HIGH FREQUENCY
Decision date: 2026-09-28
Decision code: APPR
Date received: 2025-04-09
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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).”