Allmed Systems, Inc.: FDA clearances and approvals
Allmed Systems, Inc. has 8 FDA 510(k) clearances (first 2004, latest 2014), across 1 product code in 1 review panel. Median 510(k) review time: 80 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 687 |
| 2014 | 1 | 176 |
| 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 8 | 8 |
Review panels
Most recent Allmed Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132975 | SPHINX JR | GEX | 2014-03-18 | 176 |
| K110941 | REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200 | GEX | 2013-02-19 | 687 |
| K070924 | FLEXGUARD | GEX | 2007-06-21 | 79 |
| K070466 | REVOLIX DUO LASER SYSTEM | GEX | 2007-04-17 | 60 |
| K070476 | REVOLIX 120 | GEX | 2007-03-26 | 34 |
| K051167 | REVOLIX AND REVOLIX JR | GEX | 2005-06-01 | 27 |
| K033437 | SPHINX LASER SYSTEMS | GEX | 2004-01-20 | 84 |
| K033423 | REVOLIX LASER SYSTEMS | GEX | 2004-01-15 | 80 |
Recalls
openFDA lists no recalls under a recalling firm named Allmed Systems, 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 Allmed Systems, Inc. have?
Allmed Systems, Inc. has 8 FDA 510(k) clearances (first 2004, latest 2014), across 1 product code in 1 review panel.
How long does FDA take to clear Allmed Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Allmed Systems, Inc.'s cleared 510(k)s is 80 days.
What devices does Allmed Systems, Inc. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 8).
Has Allmed Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Allmed Systems, Inc. Related entities may recall under other names.
Next steps
- See all 8 Allmed Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Allmed Systems, 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.