# K071645: Model HBP T-105 Series, Model T-105 and T-105S

- Pathway: 510(k) (Special)
- Applicant: Omron Healthcare, Inc.
- Decided: Jul 2, 2007 after 17 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: 3 generations back to K872291 (1987). 6 ancestors in all.
28 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022537: Press-Mate PM-2100 Vital Sign Monitor, Colin Medical Instruments Corp. (2002) Summary page 1.

## 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 T-105 Series Vital Signs Monitor is intended to monitor a single patient's vital signs in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel who will determine when use of this device is indicated, based upon their professional assessment of the patient's medical condition. The patient populations include adult, pediatric and neonatal. The device is capable of monitoring: * Pulse rate (via oximetry data) • Non-invasive pressure (systolic, diastolic and mean oscillometric (NIBP) • Temperature * Blood Oxygen Saturation (SpO2 via finger oximeter) This device is intended for use by qualified healthcare personnel trained in its use.

Source page: https://510kreport.com/device/K071645
Methodology: https://510kreport.com/methodology