# K022163: Welch Allyn Spot Vital Sign Monitor with MP506

- Pathway: 510(k) (Special)
- Applicant: Welch Allyn, Inc.
- Decided: Sep 17, 2002 after 76 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: 5 generations back to K962603 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002530: Welch Allyn Spot Check Device, Welch Allyn, Inc. (2000)
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories), Nellcor Puritan Bennett, Inc. (2002)

## Indications for use
The Welch Allyn Spot Vital Signs is intended for measurement of blood pressure, pulse rate, temperature and oxygen saturation (SpO2) of adult and pediatric patients. The device is not designed, sold or intended for use except as indicated. * The Welch AIlyn Spot Check Device is not designed for use with neonates. To ensure pediatric blood pressure accuracy and safety, note that the Welch Allyn small cuff (5200-03) and the small One Piece cuff (5200-13) are the smallest cuffs approved for use with young children and infants. The circumference of the child’s arm must fit within the range markings on the cuff. * The Welch Allyn Spot Check Device should not be used on patients who are linked to hearthng machines. * The Welch AIlyn Spot Check Device is not designed for use of axillary temperature option above three years of age in children. * The Welch AIlyn Spot Check Device is not intended to monitor patient’s vital signs. * The Welch AIIyn Spot Check Device is not dejibrillator proo$

Source page: https://510kreport.com/device/K022163
Methodology: https://510kreport.com/methodology