Sutter Biomedical, Inc.: FDA clearances and approvals
Sutter Biomedical, Inc. has 11 FDA 510(k) clearances (first 1981, latest 1988), across 7 product codes in 3 review panels. Median 510(k) review time: 55 days.
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 |
|---|---|---|---|
| BXB | Exerciser, Powered | 4 | 4 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 2 | 2 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 1 |
| JFA | Exerciser, Finger, Powered | 1 | 1 |
| KWH | Prosthesis, Toe, Constrained, Polymer | 1 | 1 |
| KYJ | Prosthesis, Finger, Constrained, Polymer | 1 | 1 |
| MDM | Instrument, Manual, Surgical, General Use | 1 | 1 |
Review panels
Most recent Sutter Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K875249 | SUTTER PHALANGEAL CAP | KWD | 1988-02-03 | 43 |
| K870200 | SUTTER FINGER JOINT PROSTHESIS | KYJ | 1987-10-09 | 262 |
| K861983 | SUTTER LESSER METATARSAL CAP | KWD | 1986-09-08 | 109 |
| K850274 | SUTTER CPM 9000 -NONMEASURING EXERCISE EQUIPMENT | BXB | 1985-04-25 | 92 |
| K830974 | SUTTER CPM 5000 | JFA | 1983-04-12 | 15 |
| K830649 | SUTTER CPM 2000 | BXB | 1983-03-17 | 16 |
| K823539 | SUTTER CPM | BXB | 1983-01-14 | 45 |
| K820813 | LESSER METATARSAL PHALANG. JOINT PROSTH | KWH | 1982-05-21 | 59 |
| K820083 | SUTTER CPM | BXB | 1982-01-28 | 16 |
| K812691 | SILICONE IMPLANTS | MDM | 1981-11-16 | 55 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sutter Biomedical, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances does Sutter Biomedical, Inc. have?
Sutter Biomedical, Inc. has 11 FDA 510(k) clearances (first 1981, latest 1988), across 7 product codes in 3 review panels.
How long does FDA take to clear Sutter Biomedical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Sutter Biomedical, Inc.'s cleared 510(k)s is 55 days.
What devices does Sutter Biomedical, Inc. make?
Its most frequent FDA product codes are BXB (Exerciser, Powered, 4); KWD (Prosthesis, Toe, Hemi-, Phalangeal, 2); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 1).
Has Sutter Biomedical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sutter Biomedical, Inc. Related entities may recall under other names.
Next steps
- See all 11 Sutter Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BXB, Sutter 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.