Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mdt Biologic Co. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
304 daysmedian FDA review time
882 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954736 | ACCESS (POWERCLAVE) | Mdt Biologic Co. | 1996-08-15 | 304 | 0 |
| K954940 | MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE | Mdt Biologic Co. | 1996-01-17 | 79 | 0 |
| K943654 | HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS | Mdt Biologic Co. | 1995-08-02 | 370 | 0 |
| K911087 | CASTLE WASHER/DISINFECTOR, MODEL 7550 | Mdt Biologic Co. | 1993-08-09 | 882 | 0 |
| K910777 | MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER | Mdt Biologic Co. | 1992-03-27 | 399 | 0 |
| K910778 | STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS) | Mdt Biologic Co. | 1991-10-28 | 248 | 0 |
| K910649 | MDT/CASTLE 10/90 LOAD STATION | Mdt Biologic Co. | 1991-09-06 | 204 | 0 |
| K910942 | AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT | Mdt Biologic Co. | 1991-06-11 | 97 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda