# K142356: Connex Spot Monitor,901058 Vital Signs Monitor Core

- Pathway: 510(k) (Traditional)
- Applicant: Welch Allyn, Inc.
- Decided: Dec 19, 2014 after 116 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K962603 (1997). 68 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 70 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132808: Vital Signs Monitor, Connex Vital Signs Monitor, Welch Allyn, Inc. (2013) Summary page 5.

## Most influential descendants
- K241411: Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) (2024), 0 descendants of its own

## Recalls of this device
- Mar 21, 2025 · Class II · Z-1565-2025: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- Mar 21, 2025 · Class II · Z-1564-2025: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- Aug 10, 2023 · Class II · Z-2581-2023: Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.

## Indications for use
The Connex Spot monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, 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 med/surg. floors, general hospital and alternate care environments.

Source page: https://510kreport.com/device/K142356
Methodology: https://510kreport.com/methodology