Jace Systems, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Jace Systems, Inc.” (first 1992, latest 1994), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 114 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 |
|---|---|---|---|
| BXB | Exerciser, Powered | 3 | 3 |
| JFA | Exerciser, Finger, Powered | 2 | 2 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
Review panels
Most recent Jace Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K933059 | ARTROMOT-E, ELBOW / ARTROMOT-S, SHOULDER CMP MOD. | BXB | 1994-06-22 | 365 |
| K931016 | JACE MODEL H440 HAND CPM DEVICE | JFA | 1994-06-22 | 481 |
| K931781 | JACE TRI-STIM DEVICE | IPF | 1993-10-08 | 182 |
| K922185 | JACE KNEE EXTENSION SYSTEM -- MODIFICATION | BXB | 1992-06-11 | 35 |
| K921351 | JACE MODEL PM-410 HAND CPM DEVICE | JFA | 1992-05-04 | 46 |
| K920380 | JACE MODEL W550 WRIST CPM DEVICE | BXB | 1992-02-11 | 13 |
Recalls
openFDA lists no recalls under a recalling firm named Jace Systems, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Jace Medical, LLC (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Jace Systems, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Jace Systems, Inc.” (first 1992, latest 1994), across 3 product codes 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 Jace Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Jace Systems, Inc. is 114 days.
Which FDA product codes appear under Jace Systems, Inc.?
The most frequent FDA product codes under this applicant name are BXB (Exerciser, Powered, 3); JFA (Exerciser, Finger, Powered, 2); IPF (Stimulator, Muscle, Powered, 1).
Next steps
- See all 6 Jace Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BXB, Jace Systems, 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.