LifePulse High Frequency Ventilator (HFV)
FDA premarket approval P850064/S055 · decided 2025-07-25
Approval details
- PMA number
- P850064
- Supplement
- S055
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LifePulse High Frequency Ventilator (HFV)
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- Bunnell, Inc.
- Date received
- 2024-10-02
- Decision date
- 2025-07-25
- Days to decision
- 296 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- for a change to materials in the Patient Circuit based on their biocompatibility profile. The changes include: a change to circuit tubing material (no change to tubing type or dimensions), change in the anodization process of the heater cup, and replacing the adhesives used with medical grade adhesives.
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