# K082812: Omron Model HBP-2070 Vital Signs Monitor

- Pathway: 510(k) (Special)
- Applicant: Omron Healthcare, Inc.
- Decided: Oct 22, 2008 after 28 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K872291 (1987). 8 ancestors in all.
27 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973637: Press-Mate Advantage, Colin Medical Instruments Corp. (1998) Summary page 1.
- K063690: Colin Press Mate, Model BP S510, Omron Healthcare, Inc. (2007) Summary page 4.
- K071645: Model HBP T-105 Series, Model T-105 and T-105S, Omron Healthcare, Inc. (2007) Summary page 3.

## Most influential descendants
- K112478: Visi Mobile Monitoring System (2012), 24 descendants of its own
- K122036: Visi Mobile Monitoring System (2012), 20 descendants of its own
- K130709: Visi Mobile Monitoring System (2013), 19 descendants of its own
- K133586: Visi Mobile Monitioring System (2013), 18 descendants of its own
- K143751: Visi Mobile Monitoring System (2015), 17 descendants of its own

## Indications for use
The HBP-2070 is intended to be used to monitor electrocardiography (ECG),heart rate (HR), noninvasive blood pressure (systolic, diastolic and mean arterial pressure) (NIBP), functional arterial oxygen saturation (SpO 2), pulse rate (PR), respiration (RR) temperature (Temp) for adult, pediatric, and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse, or medical specialist.

Source page: https://510kreport.com/device/K082812
Methodology: https://510kreport.com/methodology