Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sienco, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
191 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223635 | Sonoclot Coagulation & Platelet Function Analyzer System wit | Sienco, Inc. | 2023-01-04 | 30 | 0 |
| K032952 | AIACT KIT | Sienco, Inc. | 2003-12-12 | 81 | 0 |
| K002528 | SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WIT | Sienco, Inc. | 2000-08-31 | 15 | 0 |
| K984141 | GBACT + KIT | Sienco, Inc. | 1999-05-28 | 191 | 0 |
| K952560 | SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER | Sienco, Inc. | 1995-09-05 | 95 | 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