Synapse Biomedical, Inc.: FDA clearances and approvals
Synapse Biomedical, Inc. has 1 FDA 510(k) clearance (first 2025, latest 2025), plus 1 PMA decision, across 2 product codes in 2 review panels. Median 510(k) review time: 269 days. openFDA lists 2 product recalls by a recalling firm named Synapse Biomedical, Inc. It is the industry lead sponsor of 6 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2025 | 1 | 269 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Synapse Biomedical, Inc.'s cleared 510(k)s took a median 269 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 168 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GZI | Stimulator, Neuromuscular, External Functional | 1 | 1 |
| OIR | Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator | 1 | 0 |
Review panels
- Anesthesiology (1)
- Neurology (1)
Most recent Synapse Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242704 | Synchrony (20-3000) | GZI | 2025-06-05 | 269 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P200018 | PMA | NeuRX Diaphragm Pacing System (DPS) | 2023-03-31 |
Recalls
2 product recalls in 2 recall events; 2 initiated in the last five years. Most recent: 2022-07-11.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Synapse Biomedical, Inc. is the industry lead sponsor of 6 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05404477: Study of TransAeris® System for Enhanced Recovery After Surgery in France (Completed, started 2022-06-22)
- NCT04309123: Pilot Study of TransAeris® System in Surgical Patients at Risk of Prolonged Mechanical Ventilation (Completed, started 2020-03-30)
- NCT02410798: Clinical Study to Investigate Safety and Performance of TransLoc Electrodes in Patients Undergoing Surgical Procedures (Completed, started 2015-05)
- NCT02411383: Clinical Study to Investigate Safety and Performance of NeuRx DPS in Patients Undergoing Bilateral Lung Transplantation (Completed, started 2015-02)
- NCT01605006: Humanitarian Device Exemption Post-Approval Study of NeuRx Diaphragm Pacing System for Amyotrophic Lateral Sclerosis (Completed, started 2012-07)
Frequently asked questions
How many FDA 510(k) clearances does Synapse Biomedical, Inc. have?
Synapse Biomedical, Inc. has 1 FDA 510(k) clearance (first 2025, latest 2025), plus 1 PMA decision, across 2 product codes in 2 review panels.
How long does FDA take to clear Synapse Biomedical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Synapse Biomedical, Inc.'s cleared 510(k)s is 269 days.
What devices does Synapse Biomedical, Inc. make?
Its most frequent FDA product codes are GZI (Stimulator, Neuromuscular, External Functional, 1); OIR (Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator, 1).
Has Synapse Biomedical, Inc. had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Synapse Biomedical, Inc; the most recent began 2022-07-11. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 1 Synapse Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZI, Synapse Biomedical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.