# K002067: Radianalyzer, Model 12710

- Pathway: 510(k) (Traditional)
- Applicant: Radi Medical Systems AB
- Decided: Jan 11, 2001 after 188 days
- Product code: DSK (Computer, Blood-Pressure)
- Device class: 2
- Regulation: 21 CFR 870.1110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
48 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013943: Radianalyzer, Model 12710, Radiview (PC-Software Accessory), Model 12720 (2001), 47 descendants of its own
- K022188: Radianalyzer, Model 12710 (2002), 46 descendants of its own
- K042628: Modification to: Radianalyzer, Model 12711 (2005), 26 descendants of its own
- K031662: Pressure Wire Sensor, Models 12004/12304 (2003), 26 descendants of its own
- K092105: Radianalyzer Xpress (2009), 25 descendants of its own

Source page: https://510kreport.com/device/K002067
Methodology: https://510kreport.com/methodology