Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Isotechnologies, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
219 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K933063 | ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA | Isotechnologies, Inc. | 1994-01-27 | 219 | 0 |
| K912175 | ISOTECHNOLOGIES LIFTSTATION & LIFTWORKS SOFTWARE | Isotechnologies, Inc. | 1991-06-07 | 22 | 0 |
| K854621 | ISOSTATION KNEE MACHINE (K-100) | Isotechnologies, Inc. | 1986-03-07 | 109 | 0 |
| K844060 | ISOSTATION ANKLE/SUBTALAR MACHINE A-100 | Isotechnologies, Inc. | 1984-11-23 | 36 | 0 |
| K842296 | ISOSTATION LOWER BACK MACHINE | Isotechnologies, Inc. | 1984-06-22 | 11 | 0 |
| K841849 | ISOSTATION SHOULDER MACHINE | Isotechnologies, Inc. | 1984-05-14 | 11 | 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