Bunnell, Inc.: PMA supplement approved for LifePulse® High Frequency Ventilator
Bunnell, Inc. (Salt Lake City, Utah): PMA supplement approved for LifePulse® High Frequency Ventilator. Dated 37 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 8 published fields of this record are shown below. Locked: 0 related UT FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Bunnell, Inc. |
| Product | LifePulse® High Frequency Ventilator |
| Generic / ingredient | VENTILATOR, HIGH FREQUENCY |
| Approval | PMA supplement (device change) |
| Application | P850064 S056 |
| Decided | 2026-09-28 |
| Panel / class | Anesthesiology |
| Sponsor location | Salt Lake City, UT |
| Peer records CSV (1 UT records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Sponsor · Product · Approval · Decided · official source URL
- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-09-28
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FdaApprovalPulse records (UT first): Instylla, Inc. · Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) · Cerenovus, Inc. · Advanced Medical Solutions Limited · Lenstec, Inc. · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
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30 / 100 Score
What is the FdaApprovalPulse record for Bunnell, Inc. in Salt Lake City, Utah?
The FDA approved LifePulse® High Frequency Ventilator (P850064 S056) for Bunnell, Inc. on 2026-09-28: PMA supplement (device change).
How does Bunnell, Inc. compare to other Utah FdaApprovalPulse records?
It is 37 days old, still within a typical 45-day follow-up window. Its Score of 30/100 is modest; treat it as background rather than a priority.
Bunnell, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Bunnell, Inc. | Salt Lake City, UT | 2026-09-28 |
| Instylla, Inc. | Bedford, MA | 2026-10-23 |
| Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Tucson, AZ | 2026-10-23 |
| Cerenovus, Inc. | Miami, FL | 2026-10-23 |
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FdaApprovalPulse: PMA supplement (device change)
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From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.