# K053027: VSM Vital Signs Monitor, Model 53000 (VSM 300)

- Pathway: 510(k) (Special)
- Applicant: Welch Allyn, Inc.
- Decided: Nov 22, 2005 after 26 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K962603 (1997). 14 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031740: VSM - Vital Signs Monitor, Model 53000 Series, Welch Allyn Protocol, Inc. (2003) Summary page 1.

## Most influential descendants
- K072516: Midmark Diagnostics Iqmark Vital Signs Monitor (2007), 2 descendants of its own
- K161909: IQvitals Zone (2016), 1 descendant of its own
- K253196: Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) (2026), 0 descendants of its own

## Recalls of this device
- Jul 28, 2009 · Not classified · Z-1873-2009: The Welch Allyn VSM300 Vital Signs Monitor may experience a loss of audio which includes a loss of audio alarms.

## Indications for use
The VSM series of monitors is 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 (SpO2), 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 medical and surgical 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/K053027
Methodology: https://510kreport.com/methodology