Evermed, Inc.: FDA clearances and approvals
Evermed, Inc. has 9 FDA 510(k) clearances (first 1983, latest 2002), across 5 product codes in 4 review panels. Median 510(k) review time: 33 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 |
|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 4 | 4 |
| IOR | Wheelchair, Mechanical | 2 | 2 |
| DRC | Trocar | 1 | 1 |
| FKX | System, Peritoneal, Automatic Delivery | 1 | 1 |
| ITI | Wheelchair, Powered | 1 | 1 |
Review panels
Most recent Evermed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023993 | GALAXY SERIES WHEELCHAIR | IOR | 2002-12-27 | 24 |
| K024030 | MILLENNIUM SERIES MANUAL WHEELCHAIRS | IOR | 2002-12-12 | 6 |
| K023485 | EXPLORER POWERED WHEELCHAIR | ITI | 2002-12-02 | 46 |
| K840846 | STERILE HICHMAN/BROVIAC INJECTION CAP | LJS | 1984-07-06 | 133 |
| K840529 | STEIGER TUNNELING INSTRUMENT 285 | DRC | 1984-03-12 | 33 |
| K830406 | NON-STERILE CATHETER REPAIR KITS | LJS | 1983-03-01 | 22 |
| K830256 | NON-STERILE BROVIAC PARENTERAL ALIMI- | LJS | 1983-03-01 | 35 |
| K830233 | NON-STERILE,SINGLE/SOUBLE LUMEN-CATH | LJS | 1983-02-28 | 34 |
| K830257 | NON-STERILE PERITONEAL ACCESS CATHET- | FKX | 1983-02-24 | 30 |
Recalls
openFDA lists no recalls under a recalling firm named Evermed, 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 Evermed, Inc. have?
Evermed, Inc. has 9 FDA 510(k) clearances (first 1983, latest 2002), across 5 product codes in 4 review panels.
How long does FDA take to clear Evermed, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Evermed, Inc.'s cleared 510(k)s is 33 days.
What devices does Evermed, Inc. make?
Its most frequent FDA product codes are LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 4); IOR (Wheelchair, Mechanical, 2); DRC (Trocar, 1).
Has Evermed, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Evermed, Inc. Related entities may recall under other names.
Next steps
- See all 9 Evermed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJS, Evermed, 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.