Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Omnlife Science · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
168 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142201 | OMNI Interface Acetabular System | Omnlife Science | 2015-01-26 | 168 | 0 |
| K112779 | APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETAB | Omnlife Science | 2011-12-02 | 67 | 1 |
| K101994 | APEX KNEE MODULAR TIBIA SYSTEM | Omnlife Science | 2010-09-28 | 75 | 1 |
| K101575 | APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MO | Omnlife Science | 2010-06-30 | 23 | 0 |
| K100151 | APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM) | Omnlife Science | 2010-05-28 | 129 | 0 |
| K073602 | MODIFICATION TO: APEX KNEE SYSTEM | Omnlife Science | 2008-02-14 | 55 | 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