# K063690: Colin Press Mate, Model BP S510

- Pathway: 510(k) (Special)
- Applicant: Omron Healthcare, Inc.
- Decided: May 9, 2007 after 148 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
28 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K082812: Omron Model HBP-2070 Vital Signs Monitor (2008), 27 descendants of its own
- 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

## Indications for use
The Colin Press Mate, Model BP S510 is intended to be used to monitor electrocardiography (ECU), heart rate (HR), noninvasive blood pressure (systolic, diastolic and mean arterial pressures) (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration (RR), body temperature (Temp), invasive blood pressure (IBP) and capnography (EtCO 2 and InCO 2 ). The intended patient populations are: adults and pediatrics of at least 14 years of age and weighing more than 35 kg and infants can only be monitored with the oscillometric cuff. Environment of use: 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. Note: Hospital use typically includes such areas as general care floors, operating rooms, special procedure areas, intensive and critical care area, within the hospital. Hospital type facilities include physician office based facilities, sleep labs, skilled nursing facilities, surgical centers, and sub acute care centers.

Source page: https://510kreport.com/device/K063690
Methodology: https://510kreport.com/methodology