# K001671: Ultra Compact Wrist Blood Pressure Monitor with Intellisense, Model Hem-630

- Pathway: 510(k) (Special)
- Applicant: Omron Healthcare, Inc.
- Decided: Jun 30, 2000 after 29 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
No predicates in its family tree.
42 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K030359: KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor (2003), 40 descendants of its own
- K070826: KD-795 Wrist Measurement Electronic Blood Pressure Monitor (2007), 33 descendants of its own
- K090769: Fully Automatic Electronic Blood Pressure Monitor, Model KD-7961 (2009), 8 descendants of its own
- K091997: Fully Automatic Electronic Blood Pressure Monitor, Model KD-7962 (2009), 7 descendants of its own
- K150430: Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor (2015), 6 descendants of its own

Source page: https://510kreport.com/device/K001671
Methodology: https://510kreport.com/methodology