Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

QFR — Predicate Candidate Screening

8 FDA 510(k) clearances under this product code; the 50 most recent screened below.

82 daysmedian FDA review time
349 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251404Quantra QStat CartridgeHemosonics, LLC2025-08-251110
K240045QStat CartridgeHemosonics, LLC2024-03-27820
K232215Quantra Hemostasis AnalyzerHemosonics, LLC2023-08-24290
K230461Quantra Hemostasis AnalyzerHemosonics, LLC2023-03-24310
K223433Quantra QPlus SystemHemosonics, LLC2022-12-13290
K213917QStat CartridgeHemosonics, LLC2022-11-293490
K201513Quantra QPlus SystemHemosonics, LLC2020-08-21740
DEN180017Quantra Hemostasis Analyzer, QPlus CartridgeHemosonics, LLC2019-03-123440

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