Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PMS · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
98 daysmedian FDA review time
303 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233881 | ivWatch® Model 400 | Ivwatch, LLC | 2024-03-15 | 98 | 0 |
| K222212 | ivWatch Model 400 | Ivwatch, LLC | 2022-08-24 | 30 | 0 |
| K192385 | ivWatch Model 400, Device Accessories: Extension Module, Sma | Ivwatch, LLC | 2020-07-02 | 303 | 0 |
| K162478 | ivWatch | Ivwatch, LLC | 2016-12-22 | 107 | 0 |
| K153605 | ivWatch Model 400 | Ivwatch, LLC | 2016-02-11 | 56 | 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