PMA · Approved
ApprovedAvery Diaphragm Pacing System (alson known as Breathing Pacemaker System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avery Biomedical Devices, Inc. · GZE Implanted Diaphragmatic/Phrenic Nerve Stimulator
Approved on Nov 4, 2019 through premarket approval, which rests on the device’s own clinical evidence after a 768-day review.
- Decided
- Nov 4, 2019
- Review
- 768 days
- Class
- Class III
- Product code
- GZE
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
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.
Planning a device in GZE? 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? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All GZE devicesGZE Implanted Diaphragmatic/Phrenic Nerve Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · GZE
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · GZE
Too few GZE 510(k)s in any year since 2007 to give a median.
Recalls per year · GZE
No recall names GZE since 2007.
Adverse event reports per year · GZE
1in 2023
MAUDE reports naming product code GZE, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P860026/S009 · printed Nov 6, 2026
Cite this page
510(k) Report. “P860026/S009: Avery Diaphragm Pacing System (alson known as Breathing Pacemaker System).” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P860026/S009
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026