# P850064: Model 203 Life Pulse High Frequency Ventilator

- Pathway: PMA
- Applicant: Bunnell, Inc.
- Decided: Jun 30, 1988 after 1,030 days
- Product code: LSZ (Ventilator, High Frequency)
- Device class: 3
- Recalls of this device: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Nov 19, 2012 · Class I · Z-0514-2013: 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 
- Oct 25, 2010 · Not classified · Z-0902-2011: Product software coding error may compromise patient safety.
- Oct 25, 2010 · Not classified · Z-0901-2011: Product software coding error may compromise patient safety.
- Apr 4, 2005 · Not classified · Z-0893-06: 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 o

Source page: https://510kreport.com/device/P850064
Methodology: https://510kreport.com/methodology