Bowen & Company, Inc.: FDA clearances and approvals
Bowen & Company, Inc. has 14 FDA 510(k) clearances (first 1985, latest 1990), across 13 product codes in 5 review panels. Median 510(k) review time: 21 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 |
|---|---|---|---|
| HXI | Passer, Wire, Orthopedic | 2 | 2 |
| DRX | Electrode, Electrocardiograph | 1 | 1 |
| EIL | Gauge, Depth, Instrument, Dental | 1 | 1 |
| GAC | Rasp, Surgical, General & Plastic Surgery | 1 | 1 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
| HTD | Forceps | 1 | 1 |
| HTW | Bit, Drill | 1 | 1 |
| HTZ | Instrument, Cutting, Orthopedic | 1 | 1 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 1 | 1 |
Plus 3 more product codes.
Review panels
- Orthopedic (7)
- General and Plastic Surgery (4)
- Cardiovascular (1)
- Dental (1)
- General Hospital (1)
Most recent Bowen & Company, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K896898 | BOWEN ELECTRODE SKIN PREPATORY CLEANSER | LKB | 1990-04-04 | 117 |
| K896538 | DISPOSABLE 45 DEGREE SHAVER | HRX | 1989-12-06 | 20 |
| K873766 | STERNAL POWER AWL | KIJ | 1988-11-14 | 425 |
| K872098 | CREMEEN ALVEOLAR BONE CALIPER | EIL | 1987-07-31 | 60 |
| K871325 | BOWEN REUSEABLE/DISPOSABLE ELECTRODE | DRX | 1987-06-08 | 66 |
| K870882 | 45 DEGREE SHAVER | HTZ | 1987-03-23 | 18 |
| K870881 | LOOSE BODY GRASPERS | HTD | 1987-03-23 | 18 |
| K863150 | BOWEN CANNULA | GEA | 1986-09-05 | 21 |
| K863149 | BOWEN PROBE | HXB | 1986-09-05 | 21 |
| K863148 | BOWEN KNOT PASSER | HXI | 1986-09-05 | 21 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bowen & Company, 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 Bowen & Company, Inc. have?
Bowen & Company, Inc. has 14 FDA 510(k) clearances (first 1985, latest 1990), across 13 product codes in 5 review panels.
How long does FDA take to clear Bowen & Company, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Bowen & Company, Inc.'s cleared 510(k)s is 21 days.
What devices does Bowen & Company, Inc. make?
Its most frequent FDA product codes are HXI (Passer, Wire, Orthopedic, 2); DRX (Electrode, Electrocardiograph, 1); EIL (Gauge, Depth, Instrument, Dental, 1).
Has Bowen & Company, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Bowen & Company, Inc. Related entities may recall under other names.
Next steps
- See all 14 Bowen & Company, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HXI, Bowen & Company, 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.