# K032857: Press-Mate BX-10 Vital Sign Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Colin Medical Instruments Corp.
- Decided: Feb 4, 2004 after 145 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
Longest line of descent: 3 generations back to K872291 (1987). 6 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 26 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.
- K022537: Press-Mate PM-2100 Vital Sign Monitor, Colin Medical Instruments Corp. (2002) Summary page 2.

## Most influential descendants
- K113623: Patient Monitor (2012), 15 descendants of its own
- K131971: IM60/IM70 Patient Monitor (2014), 14 descendants of its own
- K160981: Patient Monitor (2016), 8 descendants of its own
- K192514: Patient Monitor (2020), 6 descendants of its own
- K202336: Patient Monitor (2021), 3 descendants of its own

## Indications for use
The Press-Mate BX-10 and BX-10An are indicated for use on adult, pediatric, and neonatal patients by a trained and qualified healthcare professional 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 Press-Mate BX-10 patient monitor is intended to monitor a single patient's non-invasive blood pressure and pulse rate. The Press-Mate BX-1OAn patient monitor is intended to monitor a single patient's non-invasive blood pressure as well as blood oxygen saturation and pulse rate via Nellcor's oximetry technology.

Source page: https://510kreport.com/device/K032857
Methodology: https://510kreport.com/methodology