Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Teftec Corp. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
230 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022652 | ALPHATRAC, MODEL A 205 | Teftec Corp. | 2002-11-21 | 104 | 0 |
| K013307 | OMEGATRAC, MODEL Z105 | Teftec Corp. | 2002-02-08 | 127 | 0 |
| K993160 | OMEGA TRAC, MODEL Z100 | Teftec Corp. | 1999-11-18 | 58 | 0 |
| K992628 | FIRSTCLASS POWER TILT AND RECLINE SEAT SYSTEM, MODEL S400 | Teftec Corp. | 1999-10-25 | 81 | 0 |
| K992627 | FIRST CLASS POWER RECLINE SEATING SYSTEM, MODEL S500 | Teftec Corp. | 1999-10-25 | 81 | 0 |
| K983066 | FIRSTCLASS POWER TILT SEAT SYSTEM, MODEL S300 | Teftec Corp. | 1998-11-27 | 86 | 0 |
| K982815 | ALPHATRAC, MODEL A200 | Teftec Corp. | 1998-11-06 | 87 | 0 |
| K955240 | OMEGATRAC BY TEFTEC | Teftec Corp. | 1996-07-01 | 230 | 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