# K241411: Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)

- Pathway: 510(k) (Traditional)
- Applicant: Welch Allyn, Inc.
- Decided: Dec 20, 2024 after 217 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K962603 (1997). 97 ancestors in all.
No later device cites it as a predicate yet.
2 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142356: Connex Spot Monitor,901058 Vital Signs Monitor Core, Welch Allyn, Inc. (2014) Summary page 5.
- K193242: Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories, Masimo Corporation (2020) Summary page 5.

## Recalls of this device
- Mar 24, 2025 · Class II · Z-1559-2025: There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not app

## 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. Monitoring respiration rate from photoplethysmogram (Masimo RRp®) is indicated for adult and pediatric patients greater than two years old. The most likely locations for patients to be monitored are general medical or surgical floors and general hospital and alternate care environments. This product is available for sale only upon the order of a physician or licensed health care professional.

Source page: https://510kreport.com/device/K241411
Methodology: https://510kreport.com/methodology