Data / Medical devices / United States / Synapse Biomedical Inc.
Synapse Biomedical Inc.: FDA-registered device maker in Oberlin, OH, United States, 1 510(k) clearance and 1 PMA approval
Synapse Biomedical Inc. is registered with the FDA (registration 3005868392) in Oberlin, OH, United States. It lists 4 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated June 5, 2025. 2 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005868392
- Address
- 300 Artino Street, Oberlin, OH, United States, 44074
- Owner or operator
- Synapse Biomedical Inc. (10024968)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 16, 2008
- Registered through
- 2027
- Brand names listed
- NeuRx DPS, NeuRx Diaphragm Pacing System, Synchrony
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator | OIR | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Goniometer, Ac-Powered | KQX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stimulator, Neuromuscular, External Functional | GZI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 5, 2025 | K242704 | Synchrony (20-3000) | GZI | Substantially Equivalent | Synapse Biomedical, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 31, 2023 | P200018 | NeuRX Diaphragm Pacing System (DPS) | OIR | 0 | March 31, 2023 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 11, 2022 | 90626 | Class I | Terminated | NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021. | Due to a defect identified on the EPG controller printed circuit board assembly, device performance may degrade over time. Depending on the failure mode, potential adverse events include pain, muscle fatigue and decreased breathing effectiveness, arrhythmia or cardiac arrest, or the device may stop unexpectedly. | accessdata.fda.gov |
| May 31, 2022 | 90386 | Class III | Terminated | NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Di | Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate storage conditions (versus transport conditions or tolerance conditions for the package material). | accessdata.fda.gov |
Compare with other makers
- All makers of Goniometer, Ac-Powered
- All makers of Stimulator, Muscle, Powered
- All makers of Stimulator, Neuromuscular, External Functional
Updated June 5, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.