Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QNL · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
211 daysmedian FDA review time
297 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233253 | eCARTv5 Clinical Deterioration Suite (“eCART”) | Agilemd, Inc. | 2024-06-21 | 267 | 0 |
| K233216 | CLEWICU System | Clew Medical , Ltd. | 2024-01-13 | 107 | 0 |
| K230842 | SignalHF (IM008) | Implicity, Inc. | 2023-10-25 | 211 | 0 |
| K231038 | Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences, LLC | 2023-07-26 | 105 | 0 |
| K200717 | CLEWICU System (ClewICUServer and ClewICUnitor) | Clew Medical , Ltd. | 2021-01-09 | 297 | 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