Genesis Industries, Inc.: FDA clearances and approvals
Genesis Industries, Inc. has 17 FDA 510(k) clearances (first 1983, latest 2000), across 5 product codes in 3 review panels. Median 510(k) review time: 68 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 |
|---|---|---|---|
| EIS | Remover, Crown | 13 | 13 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 | 1 |
| GBS | Catheter, Ventricular, General & Plastic Surgery | 1 | 1 |
| HGY | Pump, Breast, Non-Powered | 1 | 1 |
| MQK | Labware, Assisted Reproduction | 1 | 1 |
Review panels
Most recent Genesis Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K994361 | ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL | MQK | 2000-02-18 | 53 |
| K962828 | EVERT-IT | HGY | 1997-02-10 | 206 |
| K880377 | NOVO VIVO MODEL #17140 AND #17135 | GAA | 1988-04-04 | 68 |
| K880376 | NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP | GBS | 1988-02-16 | 20 |
| K833290 | C & B 40 PENTRO C & B40 | EIS | 1984-01-03 | 103 |
| K833287 | SATIN CAST ECONOCAST | EIS | 1984-01-03 | 103 |
| K833289 | C & B 61 PENTRON C & B61 | EIS | 1983-12-29 | 98 |
| K833278 | C & B 45 | EIS | 1983-12-29 | 98 |
| K833280 | SUPRA AP CHOICE 83 | EIS | 1983-12-26 | 95 |
| K833285 | RX IV PENTRON IV | EIS | 1983-12-22 | 91 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Genesis 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 Genesis Industries, Inc. have?
Genesis Industries, Inc. has 17 FDA 510(k) clearances (first 1983, latest 2000), across 5 product codes in 3 review panels.
How long does FDA take to clear Genesis Industries, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Genesis Industries, Inc.'s cleared 510(k)s is 68 days.
What devices does Genesis Industries, Inc. make?
Its most frequent FDA product codes are EIS (Remover, Crown, 13); GAA (Needle, Aspiration And Injection, Disposable, 1); GBS (Catheter, Ventricular, General & Plastic Surgery, 1).
Has Genesis Industries, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Genesis Industries, Inc. Related entities may recall under other names.
Next steps
- See all 17 Genesis Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EIS, Genesis 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.