PMA · Approved
Recalled · Class I · 2012Model 203 Life Pulse High Frequency Ventilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bunnell, Inc. · LSZ Ventilator, High Frequency
Approved on Jun 30, 1988 through premarket approval, which rests on the device’s own clinical evidence after a 1,030-day review. It has a Class I recall. It has been recalled 4 times, including a Class I recall.
- Decided
- Jun 30, 1988
- Review
- 1,030 days
- Class
- Class III
- Product code
- LSZ
- Recalls
- 4 (1 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P850064 has 48 supplements since 1989: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1989 | 2 |
| 1990 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 2 |
| 2002 | 1 |
| 2010 | 1 |
| 2013 | 2 |
| 2014 | 1 |
| 2015 | 4 |
| 2016 | 3 |
| 2017 | 3 |
| 2018 | 3 |
| 2019 | 3 |
| 2020 | 2 |
| 2021 | 3 |
| 2022 | 1 |
| 2023 | 4 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 2 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 19, 2012 | Class I | Z-0514-2013 | Component design/selection | 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… |
| Oct 25, 2010 | Not classified | Z-0902-2011 | Software design | Product software coding error may compromise patient safety. |
| Oct 25, 2010 | Not classified | Z-0901-2011 | Software design | Product software coding error may compromise patient safety. |
| Apr 4, 2005 | Not classified | Z-0893-06 | Other | 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… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LSZ devicesLSZ Ventilator, High Frequency: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LSZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LSZ
Too few LSZ 510(k)s in any year since 2007 to give a median.
Recalls per year · LSZ
2in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LSZ
72in 2025
MAUDE reports naming product code LSZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 35 |
| 2008 | 0 | — | 0 | 58 |
| 2009 | 0 | — | 0 | 35 |
| 2010 | 1 | — | 2 | 35 |
| 2011 | 0 | — | 0 | 47 |
| 2012 | 1 | — | 1 (1) | 47 |
| 2013 | 3 | — | 0 | 34 |
| 2014 | 2 | — | 0 | 29 |
| 2015 | 4 | — | 0 | 195 |
| 2016 | 3 | — | 0 | 394 |
| 2017 | 3 | — | 0 | 140 |
| 2018 | 3 | — | 0 | 88 |
| 2019 | 3 | — | 0 | 88 |
| 2020 | 2 | — | 0 | 154 |
| 2021 | 3 | — | 0 | 224 |
| 2022 | 2 | — | 1 | 220 |
| 2023 | 4 | — | 2 | 186 |
| 2024 | 4 | — | 0 | 110 |
| 2025 | 2 | — | 0 | 72 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/P850064 · printed Nov 6, 2026
Cite this page
510(k) Report. “P850064: Model 203 Life Pulse High Frequency Ventilator.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P850064
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026