Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medicnrg , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
151 daysmedian FDA review time
193 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K101177 | APEXNRG RIDER | Medicnrg , Ltd. | 2010-10-08 | 164 | 0 |
| K080113 | APEX DAL ELECTRONIC APEX LOCATOR | Medicnrg , Ltd. | 2008-02-15 | 30 | 0 |
| K071133 | APEXNRG-BLUE ELECTRONIC APEX LOCATOR | Medicnrg , Ltd. | 2007-09-21 | 151 | 0 |
| K063843 | APEXNRG XFR | Medicnrg , Ltd. | 2007-01-03 | 8 | 0 |
| K032743 | APEX NRG | Medicnrg , Ltd. | 2004-03-15 | 193 | 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