# K052671: Hoca EZ-Care BP108, Tender-Care BP109

- Pathway: 510(k) (Traditional)
- Applicant: Hoca Medical Microsystem, Inc.
- Decided: Feb 3, 2006 after 129 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 K021239 (2002). 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)
- K040159: Apm Blood Pressure Monitor, Model BP108A, Asia Pacific Microsystems, Inc. (2004) Summary page 2.

## Indications for use
The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.25" - 7.75".

Source page: https://510kreport.com/device/K052671
Methodology: https://510kreport.com/methodology