Class Class II
Quantra QStat Cartridge (K251404)
Description
Quantra QStat Cartridge by Hemosonics, LLC, an FDA 510(k) cleared hematology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251404
Clearance Date2025-08-25
Clearance TypeTraditional
Product CodeQFR
Regulation Number864.5430
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251404
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Quantra QStat Cartridge (K251404) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240045 | QStat Cartridge | Hemosonics, LLC | 2024 |
| K213917 | QStat Cartridge | Hemosonics, LLC | 2022 |
Trace the full predicate network for K251404
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.