# K040159: Apm Blood Pressure Monitor, Model BP108A

- Pathway: 510(k) (Abbreviated)
- Applicant: Asia Pacific Microsystems, Inc.
- Decided: Mar 22, 2004 after 59 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 K021239 (2002). 1 ancestor in all.
17 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021239: Eikon Automatic Digital Blood Pressure Monitor, Model HD-400M, Eikon Healthcare Device Corp. (2002) Summary page 5.

## Most influential descendants
- K051703: Clever TD-3018A Blood Pressure Monitor (2005), 8 descendants of its own
- K042795: Clever Chek TD-3213 (2005), 6 descendants of its own
- K051907: Innocor (2006), 4 descendants of its own
- K071911: Cardiopulmonary Exercise Testing Option to Innocor (2007), 3 descendants of its own
- K083879: Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath System (INN00400), Nibp (INN00500) (2009), 2 descendants of its own

## Indications for use
The device as a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate or 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 5.25”-7.75".

Source page: https://510kreport.com/device/K040159
Methodology: https://510kreport.com/methodology