Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Or-Nim Medical , Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
301 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150268 | CerOX | Or-Nim Medical , Ltd. | 2015-11-06 | 275 | 0 |
| K131854 | CEROX | Or-Nim Medical , Ltd. | 2013-09-13 | 84 | 0 |
| K100875 | CEROX, MODEL 321OF | Or-Nim Medical , Ltd. | 2011-01-25 | 301 | 0 |
| K093923 | CEROX MODEL 3210 | Or-Nim Medical , Ltd. | 2010-01-19 | 28 | 0 |
| K073407 | PACIFICA | Or-Nim Medical , Ltd. | 2008-02-28 | 86 | 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