Sun Medical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Sun Medical, Inc.” (first 1985, latest 2015), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 130 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 | 2 | 120 |
| 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 |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | 2 |
| FYD | Apparatus, Exhaust, Surgical | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| HDY | Dilator, Cervical, Hygroscopic-Laminaria | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
Review panels
Most recent Sun Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150511 | Coating Material | EBI | 2015-05-27 | 89 |
| K143265 | Acrylic Block | EBI | 2015-04-14 | 152 |
| K921963 | DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900 | HIF | 1992-09-11 | 137 |
| K911154 | SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200 | FYD | 1991-07-26 | 133 |
| K874948 | SUN MEDICAL SMOKE EVACUATOR SYSTEM | GEX | 1988-02-18 | 78 |
| K845006 | SUN MEDICAL LAMINARIA CERVICAL DILATOR | HDY | 1985-05-01 | 126 |
Recalls
openFDA lists no recalls under a recalling firm named Sun 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Sun Medical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Sun Medical, Inc.” (first 1985, latest 2015), across 5 product codes in 4 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 Sun Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sun Medical, Inc. is 130 days.
Which FDA product codes appear under Sun Medical, Inc.?
The most frequent FDA product codes under this applicant name are EBI (Resin, Denture, Relining, Repairing, Rebasing, 2); FYD (Apparatus, Exhaust, Surgical, 1); GEX (Powered Laser Surgical Instrument, 1).
Next steps
- See all 6 Sun Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBI, Sun 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.