Class Class II
Accelerate Arc System (K240854)
Description
Accelerate Arc System by Accelerate Diagnostics, Inc., an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240854
Clearance Date2024-09-26
Clearance TypeTraditional
Product CodeQNJ
Regulation Number866.3378
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240854
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. Accelerate Arc System (K240854) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K193419 | MBT Sepsityper | Bruker Daltonik GmbH | 2020 |
Trace the full predicate network for K240854
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.