Class Class II
Arm Type Blood Pressure Monitor (BPM82) (K242193)
Description
Arm Type Blood Pressure Monitor (BPM82) by Avita Corporation, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242193
Clearance Date2024-10-22
Clearance TypeTraditional
Product CodeDXN
Regulation Number870.1130
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242193
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. Arm Type Blood Pressure Monitor (BPM82) (K242193) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K112825 | AVITA ARM TYPE BLOOD PRESSURE MONITOR | Avita Corporation | 2012 |
Trace the full predicate network for K242193
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.