Epimed International, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Epimed International, Inc.” (first 1998, latest 2024), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 109 days. Since 2017 the median was 48 days, against 223 days for all cleared 510(k)s in the same product codes. 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 | 1 | 212 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 29 |
| 2020 | 1 | 48 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 268 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Epimed International, Inc. took a median 48 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 223 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 6 | 6 |
| BSO | Catheter, Conduction, Anesthetic | 4 | 4 |
| GXI | Probe, Radiofrequency Lesion | 2 | 2 |
| CAZ | Anesthesia Conduction Kit | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| GXD | Generator, Lesion, Radiofrequency | 1 | 1 |
| MIA | Needle, Spinal, Short Term | 1 | 1 |
Review panels
- Anesthesiology (12)
- Neurology (3)
- General Hospital (1)
Most recent Epimed International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232632 | Racz Neurostat RF Generator | GXD | 2024-05-24 | 268 |
| K200624 | Percutaneous Introducer | BSO | 2020-04-27 | 48 |
| K190256 | Rulo Radiofrequency Lesion Probe | GXI | 2019-03-08 | 29 |
| K133316 | SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS) | BSO | 2014-05-28 | 212 |
| K072005 | RK EPIDURAL NEEDLE | BSP | 2008-02-07 | 199 |
| K053318 | RX EPIDURAL NEEDLE | BSP | 2006-02-17 | 79 |
| K051171 | STINGRAY EPIDURAL CATHETER CONNECTOR | CAZ | 2005-08-26 | 112 |
| K051860 | FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 | MIA | 2005-08-22 | 45 |
| K043467 | FLEXIBLE SPINAL NEEDLE | BSP | 2005-03-31 | 106 |
| K041021 | RF INTRODUCTION CANNULA | GXI | 2004-09-16 | 149 |
6 earlier clearances. See the full list in Caduvo.
Recalls
11 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2021-02-01.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Epimed International, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Epimed International, Inc.” (first 1998, latest 2024), across 7 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Epimed International, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Epimed International, Inc. is 109 days. Since 2017: 48 days, versus 223 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Epimed International, Inc.?
The most frequent FDA product codes under this applicant name are BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 6); BSO (Catheter, Conduction, Anesthetic, 4); GXI (Probe, Radiofrequency Lesion, 2).
Next steps
- See all 16 Epimed International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BSP, Epimed International, 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.