Onward Medical, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Onward Medical, Inc.” (first 2025, latest 2025), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 154 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2025 | 1 | 154 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Onward Medical, Inc. took a median 154 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 154 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SDO | Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation | 2 | 1 |
Review panels
Most recent Onward Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251821 | ARC-EX System | SDO | 2025-11-14 | 154 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN240014 | De Novo | Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation | 2024-12-19 |
Recalls
openFDA lists no recalls under a recalling firm named Onward Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Onward Medical, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07147296: ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury (Recruiting, started 2025-10-17)
- NCT05284201: LIFT Home Study of Non-Invasive ARC Therapy for Spinal Cord Injury (Completed, started 2022-03-03)
- NCT04697472: The Up-LIFT Study of Non-Invasive ARC Therapy for Spinal Cord Injury (Completed, started 2021-01-08)
Frequently asked questions
How many FDA 510(k) clearances are listed under Onward Medical, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Onward Medical, Inc.” (first 2025, latest 2025), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Onward Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Onward Medical, Inc. is 154 days.
Which FDA product codes appear under Onward Medical, Inc.?
The most frequent FDA product codes under this applicant name are SDO (Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation, 2).
Next steps
- See all 1 Onward Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code SDO, Onward Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.