510(k) · Cleared
ClearedWelch Allyn Spot Ultra Vital Signs Device
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 Aug 18, 2004 as substantially equivalent to K002530 (Welch Allyn, Inc., 2000) and 1 other predicate after a 174-day review. Its family tree reaches back 2 generations to 1996. 97 later devices descend from it.
- Decided
- Aug 18, 2004
- Review
- 174 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K951193 (1996). 3 ancestors in all. 97 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK951193 Clinical Vital Signs Monitor, Model #52STP-E1Tycos Instruments, Inc. · 1996
- 1 generation backK024005 Welch Allyn Vital Sign Monitor with MP506Welch Allyn, Inc. · 2003
- This deviceK040490 Welch Allyn Spot Ultra Vital Signs DeviceWelch Allyn, Inc. · 2004
- Descendant · cites it directly · 74 of its ownK093907 Welch Allyn Non Invasive Blood Pressure (Nibp) DeviceWelch Allyn, Inc. · 2010
- Descendant · cites it directly · 73 of its ownK101445 Vital Signs Monitor-VSM 6000 SeriesWelch Allyn, Inc. · 2010
- Descendant · 2 generations on · 67 of its ownK110516 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- Descendant · 3 generations on · 66 of its ownK112687 Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- Descendant · 4 generations on · 65 of its ownK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
Showing 5 of 97 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 97 · See all- K093907Welch Allyn Non Invasive Blood Pressure (Nibp) DeviceWelch Allyn, Inc. · 2010 · cites it directly74descendants
- K101445Vital Signs Monitor-VSM 6000 SeriesWelch Allyn, Inc. · 2010 · cites it directly73descendants
- K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011 · 2 generations on67descendants
- K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011 · 3 generations on66descendants
- K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012 · 4 generations on65descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951193 | Clinical Vital Signs Monitor, Model #52STP-E1 | Tycos Instruments, Inc. | 1996 | — |
| −1 | K024005 | Welch Allyn Vital Sign Monitor with MP506 | Welch Allyn, Inc. | 2003 | — |
| 0 (this device) | K040490 | Welch Allyn Spot Ultra Vital Signs Device | Welch Allyn, Inc. | 2004 | — |
| +1 | K093907 | Welch Allyn Non Invasive Blood Pressure (Nibp) Device | Welch Allyn, Inc. | 2010 | — |
| +1 | K101445 | Vital Signs Monitor-VSM 6000 Series | Welch Allyn, Inc. | 2010 | — |
| +2 | K110516 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| +3 | K112687 | Connex (R) Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| +4 | K121013 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 8 | 0 |
| 2015 | 1 | 0 |
| 2016 | 7 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 7 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 0 |
| 2022 | 11 | 0 |
| 2023 | 6 | 0 |
| 2024 | 12 | 0 |
| 2025 | 9 | 0 |
| 2026 | 6 | 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? (2)
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 |
|---|---|---|---|
| * | K002530 | Welch Allyn Spot Check DeviceSummary page 1…e Device: Welch Allyn Spot Vital Signs Welch Allyn, Inc. 510(k) Document Control Number K002530 and K024005 Description of the Device: Indications For Use of the… | 2000 |
| * | K024005 | Welch Allyn Vital Sign Monitor with MP506Summary page 1…Welch Allyn, Inc. 510(k) Document Control Number K002530 and K024005 Description of the Device: Indications For Use of the Device: The Spot Vital Signs Ultra autom… | 2003 |
What descends from it? (97)
See all 975 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093907 | Welch Allyn Non Invasive Blood Pressure (Nibp) Device | 2010 | 74 |
| K101445 | Vital Signs Monitor-VSM 6000 Series | 2010 | 73 |
| K101680 | Welch Allyn Spot Vital Signs Lxi Model 45000 Series | 2010 | 33 |
| K100654 | Zoll Propaq MD | 2010 | 11 |
| K071642 | Mediaid M960 Series, Vital Signs Monitor and Mediaid M900 Series, Pulse Oximeter | 2008 | 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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K093907 (Welch Allyn, Inc., 2010) has gone furthest, with 74 descendants of its own.
- 2 other devices also cite its predicate K002530.
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 Spot Vital Signs Ultra automatically measures systolic and diastolic pressure, Mean Arterial Pressure (MAP), pulse rate, temperature (oral, adult axillary, pediatric axillary, rectal, and ear), and pulse oximetry (SpO2) of adult and pediatric patients. Furthermore, Spot Vital Signs Ultra allows the manual entry of height, weight, respiration, and pain level. Spot Ultra also calculates Body Mass Index (BMI) following height and weight entry.
The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040490 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040490: Welch Allyn Spot Ultra Vital Signs Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040490
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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