First Industries, Inc.: FDA clearances and approvals
First Industries, Inc. has 6 FDA 510(k) clearances (first 1981, latest 1981), across 6 product codes in 4 review panels. Median 510(k) review time: 17 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 |
|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | 1 | 1 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 | 1 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 1 | 1 |
| INP | Tips And Pads, Cane, Crutch And Walker | 1 | 1 |
| KIC | Cushion, Flotation | 1 | 1 |
| KYR | Bag, Ice | 1 | 1 |
Review panels
Most recent First Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K810652 | TUBING CONNECTORS | BYX | 1981-03-31 | 21 |
| K810651 | ORAL AIRWAYS | CAE | 1981-03-31 | 21 |
| K810654 | STOPPERLESS HOT/COLD RUBBER WATER BOTTLE | FDF | 1981-03-27 | 17 |
| K810653 | VINYL ICE BAG | KYR | 1981-03-27 | 17 |
| K810650 | CRUTCH TIPS & GRIPS | INP | 1981-03-26 | 16 |
| K810649 | INVALID CUSHION | KIC | 1981-03-26 | 16 |
Recalls
openFDA lists no recalls under a recalling firm named First Industries, 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 First Industries, Inc. have?
First Industries, Inc. has 6 FDA 510(k) clearances (first 1981, latest 1981), across 6 product codes in 4 review panels.
How long does FDA take to clear First Industries, Inc.'s 510(k)s?
The median time from FDA receipt to decision across First Industries, Inc.'s cleared 510(k)s is 17 days.
What devices does First Industries, Inc. make?
Its most frequent FDA product codes are BYX (Tubing, Pressure And Accessories, 1); CAE (Airway, Oropharyngeal, Anesthesiology, 1); FDF (Colonoscope And Accessories, Flexible/Rigid, 1).
Has First Industries, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching First Industries, Inc. Related entities may recall under other names.
Next steps
- See all 6 First Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BYX, First Industries, 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.