Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ortho Kinetics Corp. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
88 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K982088 | AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE | Ortho Kinetics Corp. | 1998-09-04 | 81 | 0 |
| K980436 | CLASS III REVERSE PULL FACEMASK | Ortho Kinetics Corp. | 1998-04-27 | 82 | 0 |
| K980245 | NITOM LOCKING FACEBOW | Ortho Kinetics Corp. | 1998-04-21 | 88 | 0 |
| K980864 | POWER COINS GLOW IN THE DARK LIGATURES | Ortho Kinetics Corp. | 1998-04-20 | 46 | 0 |
| K980151 | RELEASABLE FORCE MODULE | Ortho Kinetics Corp. | 1998-04-06 | 80 | 0 |
| K980195 | FACEBOW | Ortho Kinetics Corp. | 1998-03-11 | 50 | 0 |
| K940410 | NEW GEAR RELEASABLE HEADGEAR | Ortho Kinetics Corp. | 1994-03-10 | 42 | 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