# K024005: Welch Allyn Vital Sign Monitor with MP506

- Pathway: 510(k) (Special)
- Applicant: Welch Allyn, Inc.
- Decided: Feb 12, 2003 after 70 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: 1 generation back to K951193 (1996). 1 ancestor in all.
102 later devices descend from it; 2 cite it directly.
0 of 104 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.

## Most influential descendants
- K040490: Welch Allyn Spot Ultra Vital Signs Device (2004), 97 descendants of its own
- K093907: Welch Allyn Non Invasive Blood Pressure (Nibp) Device (2010), 74 descendants of its own
- K101445: Vital Signs Monitor-VSM 6000 Series (2010), 73 descendants of its own
- K110516: Connex Vital Signs Monitor 6000 Series (2011), 67 descendants of its own
- K112687: Connex (R) Vital Signs Monitor 6000 Series (2011), 66 descendants of its own

## Indications for use
The Welch Allyn Vital Signs Monitor is intended for monitoring 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 Allyn Vital Signs Monitor is not designed for use with neonates. To ensure pediatric blood pressure accuracy and safety, note that the Welch Allyn Small Child cuffs 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 Vital Signs Monitor should not be used on patients who are linked to heart/lung machines.

Source page: https://510kreport.com/device/K024005
Methodology: https://510kreport.com/methodology
