Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Zenith Technical Innovations — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
157 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240125 | Therm-X (Home); Therm-X (AT) | Zenith Technical Innovations | 2024-06-21 | 157 | 0 |
| K231912 | Therm-X | Zenith Technical Innovations | 2023-07-27 | 28 | 0 |
| K193550 | Therm-X | Zenith Technical Innovations | 2020-02-28 | 70 | 0 |
| K190854 | Therm-X | Zenith Technical Innovations | 2019-05-10 | 38 | 0 |
| K181149 | Therm-X Pro, Therm-X AT, Therm-X Pro Athlete | Zenith Technical Innovations | 2018-08-03 | 94 | 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