# K022783: TL100 Tensmeter Blood Pressure Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Tensys Medical, Inc.
- Decided: Nov 19, 2002 after 89 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: 2 generations back to K900247 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020537: TL10 Tensymeter Blood Pressure Monitoring System, Tensys Medical, Inc. (2002) Summary page 1.

## 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/K022783
Methodology: https://510kreport.com/methodology