# K031740: VSM - Vital Signs Monitor, Model 53000 Series

- Pathway: 510(k) (Traditional)
- Applicant: Welch Allyn Protocol, Inc.
- Decided: Aug 26, 2003 after 83 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K962603 (1997). 13 ancestors in all.
290 later devices descend from it; 6 cite it directly.
0 of 304 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951193: Clinical Vital Signs Monitor, Model #52STP-E1, Tycos Instruments, Inc. (1996) Summary page 1.
- K951246: Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography Options, Protocol Systems, Inc. (1996) Summary page 1.
- K021090: Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter, Nellcor Puritan Bennett, Inc. (2002) Summary page 1.
- K030580: Suretemp Plus, Welch Allyn, Inc. (2003) Summary page 1.

## Most influential descendants
- K063725: MP5 Intellivue Patient Monitor (2007), 175 descendants of its own
- K071426: MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90  Intellivue Patient Monitors (2007), 151 descendants of its own
- K081793: Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry System Transceiver (2008), 143 descendants of its own
- K082633: Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 (2008), 127 descendants of its own
- K083517: Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, and MP90 (2009), 125 descendants of its own

## Indications for use
The VSM series of monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, body temperature, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO*), and body temperature in normal and axillary modes of neonatal, pediatric and adult patients. The most likely locations for patients to be monitored are general med/surg. floors, general hospital and alternate care environments. This device is available for sale only upon the order of a physician or licensed health care professional.

Source page: https://510kreport.com/device/K031740
Methodology: https://510kreport.com/methodology