# K053381: Welch Allyn Connex Vital Solutions Software

- Pathway: 510(k) (Abbreviated)
- Applicant: Welch Allyn, Inc.
- Decided: Jun 15, 2006 after 192 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- 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 K001265 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001265: Welch Allyn Instrument Interface Module, Welch Allyn, Inc. (2000) Summary page 1.

## Indications for use
Welch Allyn ConnexTM (Vital Solutions Software) is intended for the collection and review of patient data, and also the communication of the data to information systems. It provides notifications when data deviates from ranges, allows manual entry of data, provides a means to identify and manage patients, and provides tools for enhancing productivity. Health care providers and trained personnel are the intended users of the system.

Source page: https://510kreport.com/device/K053381
Methodology: https://510kreport.com/methodology