Adept-Med Intl., Inc.: FDA clearances and approvals
Adept-Med Intl., Inc. has 6 FDA 510(k) clearances (first 1981, latest 1994), across 3 product codes in 2 review panels. Median 510(k) review time: 69 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 |
|---|---|---|---|
| GCZ | Retainer, Surgical | 3 | 3 |
| GAD | Retractor | 2 | 2 |
| HIB | Speculum, Vaginal, Nonmetal | 1 | 1 |
Review panels
Most recent Adept-Med Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K935636 | GRAVESPEC | HIB | 1994-03-25 | 122 |
| K893871 | GOOTT BALFOUR BLADE | GAD | 1989-08-03 | 69 |
| K893869 | GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE) | GAD | 1989-08-03 | 69 |
| K893870 | ADAMS BREAST IMPLANT PROTECTOR | GCZ | 1989-07-14 | 49 |
| K870809 | MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206 | GCZ | 1987-03-19 | 16 |
| K802806 | VISECERA RETAINER | GCZ | 1981-01-23 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Adept-Med Intl., 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 Adept-Med Intl., Inc. have?
Adept-Med Intl., Inc. has 6 FDA 510(k) clearances (first 1981, latest 1994), across 3 product codes in 2 review panels.
How long does FDA take to clear Adept-Med Intl., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Adept-Med Intl., Inc.'s cleared 510(k)s is 69 days.
What devices does Adept-Med Intl., Inc. make?
Its most frequent FDA product codes are GCZ (Retainer, Surgical, 3); GAD (Retractor, 2); HIB (Speculum, Vaginal, Nonmetal, 1).
Has Adept-Med Intl., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Adept-Med Intl., Inc. Related entities may recall under other names.
Next steps
- See all 6 Adept-Med Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCZ, Adept-Med Intl., 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.