Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PIG · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
212 daysmedian FDA review time
479 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232761 | ProNephro AKI™ (NGAL) | Bioporto Diagnostic, Inc. | 2023-12-07 | 90 | 1 |
| K210793 | VIDAS NEPHROCHECK | Biomérieux SA | 2022-07-08 | 479 | 0 |
| K171482 | NEPHROCHECK Test System | Astute Medical, Inc. | 2017-11-16 | 181 | 0 |
| K153165 | NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Co | Astute Medical, Inc. | 2016-06-01 | 212 | 0 |
| DEN130031 | NEPHROCHECK TEST SYSTEM | Astute Medical, Inc. | 2014-09-05 | 457 | 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