# K081498: Tenso-Comfort Blood Pressure Meter, Models BPM 105 and BPM 205

- Pathway: 510(k) (Traditional)
- Applicant: Biocomfort Diagnostics GmbH & Co. KG
- Decided: Dec 17, 2008 after 202 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 K021239 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051703: Clever TD-3018A Blood Pressure Monitor, Taidoc Technology Corporation (2005) Summary page 1.

## Indications for use
The tenso-comfort BPM 105 /BPM 205 is a wrist non-invasive blood pressure device which is intended for use in measuring blood pressure and pulse rate in adult patient population. The measuring method is an oscillometric blood pressure measurement with automatic sequence and refers to the auscultatory method as the reference standard. The model version BPM 105 is equipped with a radio module to transmit the measurement data to a PC. The device is not intended for neonatal use.

Source page: https://510kreport.com/device/K081498
Methodology: https://510kreport.com/methodology