# K101680: Welch Allyn Spot Vital Signs Lxi Model 45000 Series

- Pathway: 510(k) (Special)
- Applicant: Welch Allyn, Inc.
- Decided: Jul 9, 2010 after 24 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K951193 (1996). 4 ancestors in all.
33 later devices descend from it; 5 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040490: Welch Allyn Spot Ultra Vital Signs Device, Welch Allyn, Inc. (2004) Summary page 1.

## Most influential descendants
- K151644: Masimo Root Vital Signs Monitoring System and Accessories (2016), 24 descendants of its own
- K171121: Masimo Root Monitoring System and Accessories (2017), 16 descendants of its own
- K170168: Masimo Rad-97 and Accessories (2017), 14 descendants of its own
- K180046: Masimo Rad-97 and Accessories (2018), 13 descendants of its own
- K183697: Masimo Rad-97 and Accessories (2019), 9 descendants of its own

## Recalls of this device
- Mar 26, 2024 · Class II · Z-1509-2024: Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
- Apr 22, 2021 · Class II · Z-1673-2021: Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock

## 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 (SP0 2) 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/K101680
Methodology: https://510kreport.com/methodology