Biomedical Enterprises, Inc.: FDA clearances and approvals
Biomedical Enterprises, Inc. has 10 FDA 510(k) clearances (first 2002, latest 2016), across 5 product codes in 2 review panels. Median 510(k) review time: 101 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 137 |
| 2014 | 3 | 91 |
| 2015 | 2 | 99 |
| 2016 | 1 | 240 |
| 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 |
|---|---|---|---|
| JDR | Staple, Fixation, Bone | 4 | 4 |
| HRS | Plate, Fixation, Bone | 2 | 2 |
| JEY | Plate, Bone | 2 | 2 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
Review panels
- Orthopedic (8)
- Dental (2)
Most recent Biomedical Enterprises, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153573 | Converge | HRS | 2016-08-11 | 240 |
| K150125 | Elite Nitinol Fixation System | JDR | 2015-05-11 | 111 |
| K143023 | Nitinol Compression Plating System | HRS | 2015-01-16 | 87 |
| K142292 | Speed, Speed Shift, Speed Titan, Speed Arc | JDR | 2014-11-17 | 91 |
| K133270 | SPEED ARC | JDR | 2014-04-17 | 176 |
| K133520 | HAMMERLOCK 2 | HTY | 2014-01-09 | 55 |
| K124022 | SPEED SHIFT | JDR | 2013-05-14 | 137 |
| K061385 | OSSTAPLE, OSSPLATE, OSSFORCE | KWQ | 2007-05-30 | 377 |
| K023488 | OSSTAPLE, CRANIOFACIAL | JEY | 2002-10-31 | 14 |
| K023486 | OSSTAPLE, MAXILLOFACIAL | JEY | 2002-10-31 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Biomedical Enterprises, 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 Biomedical Enterprises, Inc. have?
Biomedical Enterprises, Inc. has 10 FDA 510(k) clearances (first 2002, latest 2016), across 5 product codes in 2 review panels.
How long does FDA take to clear Biomedical Enterprises, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Biomedical Enterprises, Inc.'s cleared 510(k)s is 101 days.
What devices does Biomedical Enterprises, Inc. make?
Its most frequent FDA product codes are JDR (Staple, Fixation, Bone, 4); HRS (Plate, Fixation, Bone, 2); JEY (Plate, Bone, 2).
Has Biomedical Enterprises, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Biomedical Enterprises, Inc. Related entities may recall under other names.
Next steps
- See all 10 Biomedical Enterprises, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JDR, Biomedical Enterprises, 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.