Mdt Biologic Co.: FDA clearances and approvals
Mdt Biologic Co. has 8 FDA 510(k) clearances (first 1991, latest 1996), across 6 product codes in 2 review panels. Median 510(k) review time: 276 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 |
|---|---|---|---|
| FLE | Sterilizer, Steam | 3 | 3 |
| FLF | Sterilizer, Ethylene-Oxide Gas | 1 | 1 |
| FSS | Light, Surgical, Floor Standing | 1 | 1 |
| FTA | Light, Surgical, Accessories | 1 | 1 |
| MLR | Sterilizer, Chemical | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Mdt Biologic Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954736 | ACCESS (POWERCLAVE) | FLE | 1996-08-15 | 304 |
| K954940 | MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE | FTA | 1996-01-17 | 79 |
| K943654 | HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS | MLR | 1995-08-02 | 370 |
| K911087 | CASTLE WASHER/DISINFECTOR, MODEL 7550 | — | 1993-08-09 | 882 |
| K910777 | MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER | FLE | 1992-03-27 | 399 |
| K910778 | STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS) | FLE | 1991-10-28 | 248 |
| K910649 | MDT/CASTLE 10/90 LOAD STATION | FLF | 1991-09-06 | 204 |
| K910942 | AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT | FSS | 1991-06-11 | 97 |
Recalls
openFDA lists no recalls under a recalling firm named Mdt Biologic 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 Mdt Biologic Co. have?
Mdt Biologic Co. has 8 FDA 510(k) clearances (first 1991, latest 1996), across 6 product codes in 2 review panels.
How long does FDA take to clear Mdt Biologic Co.'s 510(k)s?
The median time from FDA receipt to decision across Mdt Biologic Co.'s cleared 510(k)s is 276 days.
What devices does Mdt Biologic Co. make?
Its most frequent FDA product codes are FLE (Sterilizer, Steam, 3); FLF (Sterilizer, Ethylene-Oxide Gas, 1); FSS (Light, Surgical, Floor Standing, 1).
Has Mdt Biologic Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Mdt Biologic Co. Related entities may recall under other names.
Next steps
- See all 8 Mdt Biologic Co. clearances with predicates and recalls
- Run predicate analysis for product code FLE, Mdt Biologic 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.