Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
O'Tec Corp. — Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
13 daysmedian FDA review time
37 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K943293 | SCC22/ SCC26 SHOWER COMMODE CHAIR | O'Tec Corp. | 1994-08-19 | 42 | 0 |
| K910093 | FUTURA FEMORAL HIP STEM | O'Tec Corp. | 1991-07-01 | 174 | 0 |
| K905347 | HAGIE PIN | O'Tec Corp. | 1991-01-04 | 37 | 0 |
| K905333 | U.S. TYPE CRUCIATE SLOT BONE SCREW | O'Tec Corp. | 1991-01-04 | 37 | 0 |
| K905355 | BROAD SELF-COMPRESSING PLATE | O'Tec Corp. | 1991-01-04 | 37 | 0 |
| K905358 | CANCELLOUS SCREW | O'Tec Corp. | 1991-01-04 | 37 | 0 |
| K905357 | CORTICAL BONE SCREW (EUROPEAN STYLE) | O'Tec Corp. | 1991-01-04 | 37 | 0 |
| K905352 | BLADE PLATE | O'Tec Corp. | 1990-12-11 | 13 | 0 |
| K905341 | RUSH PIN | O'Tec Corp. | 1990-12-11 | 13 | 0 |
| K905364 | ROUND STAPLE | O'Tec Corp. | 1990-12-11 | 13 | 0 |
| K905336 | STEINMAN PIN, THREADED | O'Tec Corp. | 1990-12-11 | 13 | 0 |
| K905362 | BARBED SQUARE STAPLE | O'Tec Corp. | 1990-12-11 | 13 | 0 |
| K905345 | K-WIRE | O'Tec Corp. | 1990-12-11 | 13 | 0 |
| K905344 | KNOWLES PIN | O'Tec Corp. | 1990-12-11 | 13 | 0 |
| K905337 | STEINMAN PIN | O'Tec Corp. | 1990-12-11 | 13 | 0 |
| K905363 | FIXATION STAPLE | O'Tec Corp. | 1990-12-11 | 13 | 0 |
| K905338 | SIDE PLATE | O'Tec Corp. | 1990-12-11 | 13 | 0 |
| K905348 | HANSEN-STREET TYPE INTRAMEDULLARY NAIL | O'Tec Corp. | 1990-12-11 | 13 | 0 |
| K905349 | AUSTIN MOORE TYPE HIP PROTHESIS | O'Tec Corp. | 1990-12-11 | 13 | 0 |
| K905342 | LAG SCREW | O'Tec Corp. | 1990-12-11 | 13 | 0 |
| K905334 | THOMPSON TYPE HIP PROSTHESIS | O'Tec Corp. | 1990-12-11 | 13 | 0 |
| K905346 | JEWETT HIP NAIL | O'Tec Corp. | 1990-12-11 | 13 | 0 |
| K883034 | WHEELCHAIR BCW 6000 | O'Tec Corp. | 1988-08-02 | 14 | 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