Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NZT — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
89 daysmedian FDA review time
261 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250083 | PRO-DOSE System | Nu-Rise, SA | 2025-10-01 | 261 | 0 |
| K182395 | OARtrac System | Radialdyne, LLC | 2019-03-22 | 199 | 0 |
| K162954 | OARtrac System with Patient Specific Reusable Universal PSD | Radiadyne, LLC | 2017-06-01 | 220 | 0 |
| K150719 | OARtrac System with Skin Sensors | Radiadyne, LLC | 2015-06-16 | 89 | 0 |
| K141154 | OARTRAC SYSTEM | Radiadyne | 2014-07-22 | 78 | 0 |
| K083035 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM | Sicel Technologies, Inc. | 2008-11-13 | 30 | 0 |
| K080004 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM | Sicel Technologies, Inc. | 2008-01-23 | 21 | 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