Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Onefit Medical — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
179 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173390 | hipEOS | Onefit Medical | 2018-04-27 | 179 | 0 |
| K161828 | kneeEOS | Onefit Medical | 2016-10-03 | 90 | 0 |
| K161479 | hipEOS | Onefit Medical | 2016-06-28 | 28 | 0 |
| K160407 | spineEOS | Onefit Medical | 2016-04-08 | 52 | 0 |
| K142671 | ONEFIT HIP PLANNER | Onefit Medical | 2014-12-05 | 77 | 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