# K040490: Welch Allyn Spot Ultra Vital Signs Device

- Pathway: 510(k) (Abbreviated)
- Applicant: Welch Allyn, Inc.
- Decided: Aug 18, 2004 after 174 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: 2 generations back to K951193 (1996). 3 ancestors in all.
97 later devices descend from it; 5 cite it directly.
0 of 101 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) Summary page 1.
- K024005: Welch Allyn Vital Sign Monitor with MP506, Welch Allyn, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K121013: Connex Vital Signs Monitor 6000 Series (2012), 65 descendants of its own

## Indications for use
The Spot Vital Signs Ultra automatically measures systolic and diastolic pressure, Mean Arterial Pressure (MAP), pulse rate, temperature (oral, adult axillary, pediatric axillary, rectal, and ear), and pulse oximetry (SpO2) of adult and pediatric patients. Furthermore, Spot Vital Signs Ultra allows the manual entry of height, weight, respiration, and pain level. Spot Ultra also calculates Body Mass Index (BMI) following height and weight entry. The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.

Source page: https://510kreport.com/device/K040490
Methodology: https://510kreport.com/methodology