# K093981: Yrnsortip Oximanometer

- Pathway: 510(k) (Traditional)
- Applicant: Cnoga Medical, Ltd.
- Decided: Jul 22, 2010 after 210 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K880572 (1988). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043217: A&D Medical UA-767PBT Digital Blood Pressure Monitor, A&D Engineering, Inc. (2005) Summary page 2.
- K023723: Finometer Noninvasive Hemodynamic Monitor, Model 1, Fms, Finapres Medical Systems BV (2003) Summary page 2.
- K023338: Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor,Model-2, Fms, Finapres Medical Systems BV (2003) Summary page 2.

## Most influential descendants
- K190893: Non-invasive Hemodynamic Blood Pressure Monitor (2019), 0 descendants of its own

## Indications for use
The TensorTip - Non-invasive Hemodynamic blood pressure monitor trending device is a small, lightweight, handheld, device intended for measuring and display of Blood Pressure trending (systolic and diastolic) and spot-check of Peripheral pulse rate (PPR) and Peripheral pulse wave (PPW). Measurement is performing on capillary finger tip tissue (other than the thumb). The ring finger is the recommended site. The results of each measurement are stored in the system memory. The device is intended for use in the home environment. It is intended to be used by any person aged above 18 years old

Source page: https://510kreport.com/device/K093981
Methodology: https://510kreport.com/methodology
