510(k) · Cleared
ClearedWelch Allyn Non Invasive Blood Pressure (Nibp) 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 Apr 14, 2010 as substantially equivalent to K063419 (Welch Allyn Protocol, Inc., 2006) and 1 other predicate after a 113-day review. Its family tree reaches back 8 generations to 1997. 74 later devices descend from it.
- Decided
- Apr 14, 2010
- Review
- 113 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K962603 (1997). 18 ancestors in all, the oldest K904039 (1990). 74 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 7 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 6 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 5 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 4 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 3 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 2 generations backK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- 1 generation backK063419 Modification to VSM- Vital Signs Monitor, (VSM 300 )Welch Allyn Protocol, Inc. · 2006 · Recalled
- This deviceK093907 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
- Descendant · 5 generations on · 58 of its ownK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
Showing 5 of 74 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 74 · See all- 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
- K140188Masimo Root Monitoring SystemMasimo Corporation · 2014 · 5 generations on58descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −7 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −6 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −5 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −4 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −3 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −2 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
| −1 | K063419 | Modification to VSM- Vital Signs Monitor, (VSM 300 ) | Welch Allyn Protocol, Inc. | 2006 | 1 |
| 0 (this device) | 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 | — |
| +5 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 7 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 10 | 0 |
| 2023 | 6 | 0 |
| 2024 | 10 | 0 |
| 2025 | 8 | 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 |
|---|---|---|---|
| * | K063419 | Modification to VSM- Vital Signs Monitor, (VSM 300 )Summary page 1…pressure measurement system Class 1I; Product Code: DXN- 21 CFR 870.1130 Predicate Devices: Modification to VSM- Vital Signs Monitor (VSM 300) (K063419) Welch Allyn Spot Ultra Vital Signs Device (K040490) Description: The Welch Allyn NIBP device co… | 2006 |
| * | K040490 | Welch Allyn Spot Ultra Vital Signs DeviceSummary page 1…XN- 21 CFR 870.1130 Predicate Devices: Modification to VSM- Vital Signs Monitor (VSM 300) (K063419) Welch Allyn Spot Ultra Vital Signs Device (K040490) Description: The Welch Allyn NIBP device consists of 1) a software program running on a laptop… | 2004 |
What descends from it? (74)
See all 741 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101445 | Vital Signs Monitor-VSM 6000 Series | 2010 | 73 |
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 13 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 18 ancestors have a recall of any class.
- Of its descendants, K101445 (Welch Allyn, Inc., 2010) has gone furthest, with 73 descendants of its own.
- 1 other device also cites its predicate K063419.
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. 2010, this device’s year, is highlighted.
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 Non-Invasive Blood Pressure device is intended to be used by clinicians and medically qualified personnel for the acquisition and attended monitoring of noninvasive blood pressure and pulse rate of neonatal through adult patients. The Welch Allyn Non-Invasive Blood Pressure device may be used for treatment and diagnostic spot NIBP measurements or attended NIBP monitoring in hospital general wards, clinics, and doctor's offices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093907 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093907: Welch Allyn Non Invasive Blood Pressure (Nibp) Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093907
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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