Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Med-Tec,Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
149 daysmedian FDA review time
406 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K034054 | PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 | Med-Tec,Inc. | 2004-02-20 | 52 | 0 |
| K031866 | MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC | Med-Tec,Inc. | 2003-08-14 | 59 | 0 |
| K021360 | SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000 | Med-Tec,Inc. | 2003-06-10 | 406 | 0 |
| K023293 | MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02 | Med-Tec,Inc. | 2002-12-23 | 82 | 0 |
| K013875 | MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE | Med-Tec,Inc. | 2002-09-27 | 308 | 0 |
| K001052 | MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX | Med-Tec,Inc. | 2000-08-30 | 149 | 0 |
| K981992 | ELECTRON WEDGE MODEL MT-EW-1000 | Med-Tec,Inc. | 1998-12-15 | 190 | 0 |
| K982624 | MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 | Med-Tec,Inc. | 1998-10-26 | 90 | 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