Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
PTF · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242294 | DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibra | Diasys Diagnostic Systems GmbH | 2025-05-09 | 280 | 0 |
| K222996 | Access PCT | Beckman Coulter, Inc. | 2023-04-26 | 210 | 0 |
| K192271 | Access PCT, Access PCT Calibrators | Beckman Coulter, Inc. | 2019-11-26 | 96 | 1 |
| K162297 | Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PC | Diazyme Laboratories | 2017-04-18 | 245 | 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