Solway, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Solway, Inc.” (first 1987, latest 1988), across 12 product codes in 6 review panels. Median 510(k) review time under this name: 28 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HTD | Forceps | 2 | 2 |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 1 |
| EKJ | Burnisher, Operative | 1 | 1 |
| GDR | Saw, Manual And Accessories | 1 | 1 |
| GWX | Fork, Tuning | 1 | 1 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 1 | 1 |
| HAE | Rongeur, Manual | 1 | 1 |
| HAO | Instrument, Surgical, Non-Powered | 1 | 1 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | 1 | 1 |
| HNA | Spud, Ophthalmic | 1 | 1 |
Plus 2 more product codes.
Review panels
- Neurology (5)
- General and Plastic Surgery (4)
- Cardiovascular (1)
- Dental (1)
- Ophthalmic (1)
- Orthopedic (1)
Most recent Solway, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K874960 | CARDIOVASCULAR SURGICAL INSTRUMENTS | DWS | 1988-02-05 | 65 |
| K874962 | FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS | HAO | 1988-02-02 | 62 |
| K874956 | SELF-RETAINING RETRACTOR FOR NEUROSURGERY | GZT | 1988-01-28 | 57 |
| K874964 | DENTAL HAND INSTRUMENTS | EKJ | 1988-01-27 | 56 |
| K875043 | RONGEUR (NEUROSURGICAL INSTRUMENTS) | HAE | 1988-01-22 | 51 |
| K874966 | TUNING FORKS | GWX | 1988-01-04 | 33 |
| K874965 | MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE | HTD | 1987-12-30 | 28 |
| K874961 | BONE CUTTING INSTRUMENTS & ACCESSORIES | GDR | 1987-12-30 | 28 |
| K874959 | VASCULAR CLAMP | HXD | 1987-12-30 | 28 |
| K874954 | MANUAL RONGEUR | HTX | 1987-12-30 | 28 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Solway, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Solway, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Solway, Inc.” (first 1987, latest 1988), across 12 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Solway, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Solway, Inc. is 28 days.
Which FDA product codes appear under Solway, Inc.?
The most frequent FDA product codes under this applicant name are HTD (Forceps, 2); DWS (Instruments, Surgical, Cardiovascular, 1); EKJ (Burnisher, Operative, 1).
Next steps
- See all 13 Solway, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HTD, Solway, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.