Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
OBE · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250814 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SS | Zeus Scientific | 2026-05-08 | 417 | 0 |
| K141655 | QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA | Inova Diagnostics, Inc. | 2015-03-05 | 258 | 0 |
| K063565 | QUANTA LITE SS-A 52 ELISA | Inova Diagnostics, Inc. | 2007-04-04 | 127 | 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