Benson Medical Instruments Co.: FDA clearances and approvals
Benson Medical Instruments Co. has 5 FDA 510(k) clearances (first 1993, latest 2013), across 3 product codes in 2 review panels. Median 510(k) review time: 89 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 266 |
| 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 |
|---|---|---|---|
| EWO | Audiometer | 3 | 3 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| EWG | Laser, Ent Microsurgical Carbon-Dioxide | 1 | 1 |
Review panels
Most recent Benson Medical Instruments Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123896 | CCS-200 SPIROMETER | BZG | 2013-09-10 | 266 |
| K982441 | CCA-220 | EWO | 1998-10-09 | 87 |
| K981439 | CCA-200 | EWO | 1998-06-15 | 55 |
| K963681 | CCA-100 (MODIFIED) | EWO | 1996-10-08 | 89 |
| K924652 | BENSON CCA100 | EWG | 1993-04-09 | 206 |
Recalls
openFDA lists no recalls under a recalling firm named Benson Medical Instruments Co..
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 Benson Medical Instruments Co. have?
Benson Medical Instruments Co. has 5 FDA 510(k) clearances (first 1993, latest 2013), across 3 product codes in 2 review panels.
How long does FDA take to clear Benson Medical Instruments Co.'s 510(k)s?
The median time from FDA receipt to decision across Benson Medical Instruments Co.'s cleared 510(k)s is 89 days.
What devices does Benson Medical Instruments Co. make?
Its most frequent FDA product codes are EWO (Audiometer, 3); BZG (Spirometer, Diagnostic, 1); EWG (Laser, Ent Microsurgical Carbon-Dioxide, 1).
Has Benson Medical Instruments Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Benson Medical Instruments Co. Related entities may recall under other names.
Next steps
- See all 5 Benson Medical Instruments Co. clearances with predicates and recalls
- Run predicate analysis for product code EWO, Benson Medical Instruments Co.'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.