# K023495: Welch Allyn Vitals Software Developers Kit (SDK)

- Pathway: 510(k) (Special)
- Applicant: Welch Allyn, Inc.
- Decided: Oct 31, 2002 after 13 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: 1 generation back to K001265 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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)

## Most influential descendants
- K052784: Device Connectivity Software Developers Kit (SDK), Model 4500-900 (2005), 0 descendants of its own

## Indications for use
The Vitals Software Developer’s Kit (SDK) is an Original Equipment Manufacturer (OEM) software product that will be licensed to Computerized Patient Record (CPR) manufacturers who will integrate it with and sell it as part of their CPR system. The SDK is designed to communicate with and collect data from diagnostic instruments using an instrument specific interface that is compatible with the instrument’s existing communications capability. Existing instruments will not have to be changed. The data that is collected will be displayed for the user to verify before it is sent to the CPR where it is saved as part of the CPR’s database. For access by the CPR, the data is translated from its original form into industry standard software object form (XML, Active X, COM). The SDK also provides sample program software that demonstrates how to display the data in the appropriate form. The SDK is required for both the collection and the retrievalheview of data. The SDK will also provide the necessary set-up or configuration guidelines and help files that will allow the user to designate which instruments are connected to a personal computer (PC) at a specific location.

Source page: https://510kreport.com/device/K023495
Methodology: https://510kreport.com/methodology