# K020537: TL10 Tensymeter Blood Pressure Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Tensys Medical, Inc.
- Decided: Aug 15, 2002 after 177 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: 1 generation back to K900247 (1990). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900247: CBM-3000/CBM-2000/CBM-7000 Blood Pressure System, Colin Medical Instruments Corp. (1990) Summary page 1.

## Most influential descendants
- K223873: Boppli Infant Blood Pressure Monitor (2023), 0 descendants of its own
- K201302: LiveOne (2022), 0 descendants of its own
- K022783: TL100 Tensmeter Blood Pressure Monitoring System (2002), 0 descendants of its own

## Indications for use
This device is intended for use by medically trained personnel in a clinical setting to continually monitor and display diastolic, systolic, and mean blood pressures and pulse rate. The device is intended for use on adult patients with a palpable pulse.

Source page: https://510kreport.com/device/K020537
Methodology: https://510kreport.com/methodology