510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Welch Allyn Spot Vital Signs Lxi Model 45000 Series

K101680510(k) SpecialCleared Jul 9, 201024-day reviewClass II21 CFR 870.1130Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Welch Allyn, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Jul 9, 2010 as substantially equivalent to K040490 (Welch Allyn, Inc., 2004) after a 24-day review. Its family tree reaches back 3 generations to 1996. 33 later devices descend from it. It has been recalled 2 times.

Decided
Jul 9, 2010
Review
24 days
Class
Class II
Product code
DXN
Recalls
2
Predicates
1

Its longest line of descent runs back 3 generations to K951193 (1996). 4 ancestors in all. 33 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2016: 4 descendants cleared2014: 1 descendant cleared2022: 2 descendants cleared2024: 5 descendants cleared2017: 2 descendants cleared2020: 6 descendants cleared2018: 1 descendant cleared2023: 4 descendants cleared2019: 3 descendants cleared2025: 2 descendants cleared2026: 2 descendants cleared2021: 1 descendant clearedK951193 · Clinical Vital Signs Monitor, Model #52STP-E1 · Tycos Instruments, Inc. · 1996K024005 · Welch Allyn Vital Sign Monitor with MP506 · Welch Allyn, Inc. · 2003K040490 · Welch Allyn Spot Ultra Vital Signs Device · Welch Allyn, Inc. · 20041995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 5 descendants3 generations forward: 7 descendants4 generations forward: 13 descendants5 generations forward: 3 descendants K040490 · Welch Allyn Spot Ultra Vital Signs Device · Welch Allyn, Inc. · 2004K024005 · Welch Allyn Vital Sign Monitor with MP506 · Welch Allyn, Inc. · 2003K951193 · Clinical Vital Signs Monitor, Model #52STP-E1 · Tycos Instruments, Inc. · 19960+5
  1. Root · 3 generations backK951193 Clinical Vital Signs Monitor, Model #52STP-E1Tycos Instruments, Inc. · 1996
  2. 2 generations backK024005 Welch Allyn Vital Sign Monitor with MP506Welch Allyn, Inc. · 2003
  3. 1 generation backK040490 Welch Allyn Spot Ultra Vital Signs DeviceWelch Allyn, Inc. · 2004
  4. This deviceK101680 Welch Allyn Spot Vital Signs Lxi Model 45000 SeriesWelch Allyn, Inc. · 2010
  5. Descendant · cites it directly · 24 of its ownK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
  6. Descendant · 2 generations on · 16 of its ownK171121 Masimo Root Monitoring System and AccessoriesMasimo Corporation · 2017
  7. Descendant · 2 generations on · 14 of its ownK170168 Masimo Rad-97 and AccessoriesMasimo Corporation · 2017
  8. Descendant · 3 generations on · 13 of its ownK180046 Masimo Rad-97 and AccessoriesMasimo Corporation · 2018 · Recalled
  9. Descendant · 4 generations on · 9 of its ownK183697 Masimo Rad-97 and AccessoriesMasimo Corporation · 2019

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2014: 12016: 42017: 22018: 12019: 32020: 62021: 12022: 22023: 42024: 52025: 22026: 2
2014high 6 (2020) · low 0 (2015)2026

Most influential descendants

Showing 5 of 33 · See all
  • K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016 · cites it directly24descendants
  • K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation · 2017 · 2 generations on16descendants
  • K170168Masimo Rad-97 and AccessoriesMasimo Corporation · 2017 · 2 generations on14descendants
  • K180046Masimo Rad-97 and AccessoriesMasimo Corporation · 2018 · 3 generations on13descendants
  • K183697Masimo Rad-97 and AccessoriesMasimo Corporation · 2019 · 4 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K951193Clinical Vital Signs Monitor, Model #52STP-E1Tycos Instruments, Inc.1996—
−2K024005Welch Allyn Vital Sign Monitor with MP506Welch Allyn, Inc.2003—
−1K040490Welch Allyn Spot Ultra Vital Signs DeviceWelch Allyn, Inc.2004—
0 (this device)K101680Welch Allyn Spot Vital Signs Lxi Model 45000 SeriesWelch Allyn, Inc.2010—
+1K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation2016—
+2K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation2017—
+2K170168Masimo Rad-97 and AccessoriesMasimo Corporation2017—
+3K180046Masimo Rad-97 and AccessoriesMasimo Corporation20181
+4K183697Masimo Rad-97 and AccessoriesMasimo Corporation2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201640
201720
201810
201930
202060
202110
202220
202340
202450
202520
202620
FIG. 1 — Lineage of K101680, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K040490Welch Allyn Spot Ultra Vital Signs Device
Summary page 1
…evice: Welch Allyn Spot Ultra Vital Signs Welch Allyn, Inc. 510(k) Document Control Number K040490 Special 510(k) -Spot Vital Signs Lxi Page 1of 5 Weic1~Alyn- Descrip…
Welch Allyn, Inc.2004—

Also cleared against K040490: 4 other devices →

What descends from it? (33)

See all 33

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624
K133810VC150 Vital Signs MonitorInnokas Yhtyma20143
K160439SunTech CT40 Spot-check Vital Signs DeviceSuntech Medical20161
K152831Spot SkanSkanray Technologies Private Limited20160
K151512Star 60Skanray Technologies Private Limited20160

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 26, 2024Class IIZ-1509-2024Nonconforming Material/ComponentBaxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
Apr 22, 2021Class IIZ-1673-2021Device DesignPotential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 5.9 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K151644 (Masimo Corporation, 2016) has gone furthest, with 24 descendants of its own.
  • 4 other devices also cite its predicate K040490.

How does its category compare?

All DXN devices

DXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · DXN

28in 2025

2007: 272008: 232009: 462010: 432011: 342012: 362013: 342014: 292015: 302016: 302017: 332018: 222019: 332020: 242021: 232022: 252023: 352024: 172025: 282026 (partial year): 29
2007high 46 (2009) · low 17 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXN

142in 2025

2007: 118 days median2008: 82 days median2009: 73 days median2010: 94 days median2011: 72 days median2012: 116 days median2013: 150 days median2014: 133 days median2015: 97 days median2016: 144 days median2017: 184 days median2018: 235 days median2019: 156 days median2020: 198 days median2021: 190 days median2022: 137 days median2023: 182 days median2024: 107 days median2025: 142 days median2026 (partial year): 147 days median
2007high 235 (2018) · low 72 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXN

3in 2024

2008: 12009: 32011: 12013: 12016: 12019: 12024: 3
2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXN

239in 2025

2007: 212008: 82009: 172010: 142011: 102012: 192013: 722014: 472015: 622016: 542017: 902018: 6172019: 962020: 1302021: 1622022: 1552023: 1622024: 2702025: 239
2007high 617 (2018) · low 8 (2008)2025

MAUDE reports naming product code DXN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200727118021
2008238218
20094673317
20104394014
20113472110
201236116019
201334150172
201429133047
20153097062
201630144154
201733184090
2018222350617
201933156196
2020241980130
2021231900162
2022251370155
2023351820162
2024171073270
2025281420239
2026291470—

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 (SP0 2) 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.

Also cleared against K040490

4 other devices cite the same predicate.

  • K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters · 2010
  • K101445Vital Signs Monitor-VSM 6000 SeriesWelch Allyn, Inc. · 2010
  • K093907Welch Allyn Non Invasive Blood Pressure (Nibp) DeviceWelch Allyn, Inc. · 2010
  • K071642Mediaid M960 Series, Vital Signs Monitor and Mediaid M900 Series, Pulse OximeterMediaid, Inc. · 2008

More from Welch Allyn, Inc.

111 FDA decisions under this applicant name. See the company

  • K243598Welch Allyn Connex® 360 (Multiple)Welch Allyn, Inc. · 2025
  • K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc. · 20241 recall
  • K223381iExaminer System with Panoptic PlusWelch Allyn, Inc. · 2023
  • K212473Welch Allyn Connex Central StationWelch Allyn, Inc. · 2022
  • K191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionWelch Allyn, Inc. · 20191 recall

Recent decisions in DXN

The DXN category page

  • K260470Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C…Shenzhen Brav Electronic Technologies Co., Ltd. · 2026
  • K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc. · 2026
  • K254000Happy Health Blood Pressure MonitorHappy Health, Inc. · 2026
  • K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd. · 2026
  • K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus…JOYTECH Healthcare Co., Ltd. · 2026

https://510kreport.com/device/K101680 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101680: Welch Allyn Spot Vital Signs Lxi Model 45000 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101680

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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