510(k) · Cleared
ClearedWelch Allyn Vitals Software Developers Kit (SDK)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Oct 31, 2002 as substantially equivalent to K001265 (Welch Allyn, Inc., 2000) after a 13-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Oct 31, 2002
- Review
- 13 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001265 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK001265 Welch Allyn Instrument Interface ModuleWelch Allyn, Inc. · 2000
- This deviceK023495 Welch Allyn Vitals Software Developers Kit (SDK)Welch Allyn, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK052784 Device Connectivity Software Developers Kit (SDK), Model 4500-900Welch Allyn, Inc. · 2005
Most influential descendants
Showing 1 of 1 · See all- K052784Device Connectivity Software Developers Kit (SDK), Model 4500-900Welch Allyn, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001265 | Welch Allyn Instrument Interface Module | Welch Allyn, Inc. | 2000 | — |
| 0 (this device) | K023495 | Welch Allyn Vitals Software Developers Kit (SDK) | Welch Allyn, Inc. | 2002 | — |
| +1 | K052784 | Device Connectivity Software Developers Kit (SDK), Model 4500-900 | Welch Allyn, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K001265 | Welch Allyn Instrument Interface Module | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052784 | Device Connectivity Software Developers Kit (SDK), Model 4500-900 | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
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…
Read the full statement (191 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023495: Welch Allyn Vitals Software Developers Kit (SDK).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023495
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026