# K022537: Press-Mate PM-2100 Vital Sign Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Colin Medical Instruments Corp.
- Decided: Sep 13, 2002 after 43 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: 2 generations back to K872291 (1987). 5 ancestors in all.
50 later devices descend from it; 3 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890876: BP-8800 Blood Pressure Monitor, Colin Medical Instruments Corp. (1989) Summary page 2.
- K921048: BP8800T/8000IR/8300G Non-Invasive Blood Pres. Syst, Colin Medical Instruments Corp. (1993) Summary page 3.
- K942871: Press-Mate BP8800MS Automatic Non-Invasive Blood Pressure System, Colin Medical Instruments Corp. (1994) Summary page 3.
- K973637: Press-Mate Advantage, Colin Medical Instruments Corp. (1998) Summary page 2.

## Most influential descendants
- K071645: Model HBP T-105 Series, Model T-105 and T-105S (2007), 28 descendants of its own
- 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

## Indications for use
The Press-Mate PM-2100 patient monitor is intended to monitor a single patient’s vital signs in the hospital, outpatient surgery 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 (SPO, via finger oximeter) This device is intended for use by qualified healthcare personnel trained in its use.

Source page: https://510kreport.com/device/K022537
Methodology: https://510kreport.com/methodology