Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Disco-O-Tech Medical Technologies, Ltd. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
93 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K032588 | MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION | Disco-O-Tech Medical Technologies, Ltd. | 2003-09-12 | 21 | 0 |
| K031401 | FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) | Disco-O-Tech Medical Technologies, Ltd. | 2003-08-06 | 93 | 0 |
| K023437 | FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SY | Disco-O-Tech Medical Technologies, Ltd. | 2002-11-14 | 30 | 0 |
| K021324 | FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYST | Disco-O-Tech Medical Technologies, Ltd. | 2002-05-23 | 27 | 1 |
| K012967 | MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAME | Disco-O-Tech Medical Technologies, Ltd. | 2001-10-04 | 30 | 1 |
| K003212 | FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) | Disco-O-Tech Medical Technologies, Ltd. | 2000-12-28 | 76 | 0 |
| K003215 | MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION | Disco-O-Tech Medical Technologies, Ltd. | 2000-12-27 | 75 | 0 |
| K002783 | FIXION INTERLOCKING NAIL (FIXION IL NAIL) | Disco-O-Tech Medical Technologies, Ltd. | 2000-12-05 | 90 | 0 |
| K990717 | FIXION INTRAMEDULLARY NAILING SYSTEM | Disco-O-Tech Medical Technologies, Ltd. | 1999-06-02 | 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