Sutter Corp.: FDA clearances and approvals
Sutter Corp. has 7 FDA 510(k) clearances (first 1989, latest 1995), across 3 product codes in 2 review panels. Median 510(k) review time: 124 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 | 5 | 5 |
| KWH | Prosthesis, Toe, Constrained, Polymer | 1 | 1 |
| KYJ | Prosthesis, Finger, Constrained, Polymer | 1 | 1 |
Review panels
- Physical Medicine (5)
- Orthopedic (2)
Most recent Sutter Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943354 | SUTTER HAMMERTOE JOINT PROSTHESIS | KWH | 1995-06-12 | 335 |
| K945221 | SUTTER MODEL 6000 HAND CPM DEVICE | BXB | 1995-02-27 | 124 |
| K931588 | SUTTER PROXIMAL INTERPHALANGEAL JOINT | KYJ | 1994-03-10 | 344 |
| K924654 | FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT | BXB | 1993-02-22 | 160 |
| K914860 | SUTTER MODEL 10000 LEG CPM DEVICE | BXB | 1992-01-08 | 71 |
| K902707 | MODEL 9000 AT ANKLE CPM DEVICE | BXB | 1990-07-25 | 36 |
| K890607 | SUTTER HOSPITAL CPM | BXB | 1989-02-27 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Sutter Corp..
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 Corp. have?
Sutter Corp. has 7 FDA 510(k) clearances (first 1989, latest 1995), across 3 product codes in 2 review panels.
How long does FDA take to clear Sutter Corp.'s 510(k)s?
The median time from FDA receipt to decision across Sutter Corp.'s cleared 510(k)s is 124 days.
What devices does Sutter Corp. make?
Its most frequent FDA product codes are BXB (Exerciser, Powered, 5); KWH (Prosthesis, Toe, Constrained, Polymer, 1); KYJ (Prosthesis, Finger, Constrained, Polymer, 1).
Has Sutter Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sutter Corp. Related entities may recall under other names.
Next steps
- See all 7 Sutter Corp. clearances with predicates and recalls
- Run predicate analysis for product code BXB, Sutter Corp.'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.