510(k) · Cleared
ClearedDevice Connectivity Software Developers Kit (SDK), Model 4500-900
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 Nov 22, 2005 as substantially equivalent to K023495 (Welch Allyn, Inc., 2002) after a 50-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Nov 22, 2005
- Review
- 50 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001265 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK001265 Welch Allyn Instrument Interface ModuleWelch Allyn, Inc. · 2000
- 1 generation backK023495 Welch Allyn Vitals Software Developers Kit (SDK)Welch Allyn, Inc. · 2002
- This deviceK052784 Device Connectivity Software Developers Kit (SDK), Model 4500-900Welch Allyn, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001265 | Welch Allyn Instrument Interface Module | Welch Allyn, Inc. | 2000 | — |
| −1 | K023495 | Welch Allyn Vitals Software Developers Kit (SDK) | Welch Allyn, Inc. | 2002 | — |
| 0 (this device) | K052784 | Device Connectivity Software Developers Kit (SDK), Model 4500-900 | Welch Allyn, Inc. | 2005 | — |
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 |
|---|---|---|---|
| * | K023495 | Welch Allyn Vitals Software Developers Kit (SDK)Summary page 1…Welch Allyn Inc. 4341 State Street Road Skaneateles Falls, NY 13 153-0220 5 10(k) Number: K023495 5 10(k) Summary I of 5 WelccAllyny Description… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 3.1 years on median.
- None of the 2 ancestors has a recall.
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 Welch Allyn Device Connectivity Software Developers Kit (SDK) is an Original Equipment Manufacturer (OEM) software product that will be integrated into software applications, such as Computerized Patient Record (CPR) systems. The Device Connectivity SDK is designed to communicate with and collect data from electronic diagnostic devices to enable an application to request, retrieve and review device data.
The Device Connectivity SDK is an enabling data communication tool and is not intended to be an end, finished product.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052784 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052784: Device Connectivity Software Developers Kit (SDK), Model 4500-900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052784
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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