510(k) · Cleared
ClearedSphygmocor Xcel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atcor Medical · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Nov 16, 2012 as substantially equivalent to K070795 (Atcor Medical Pty, Ltd., 2007) and 2 other predicates after a 121-day review. Its family tree reaches back 7 generations to 1991. 6 later devices descend from it.
- Decided
- Nov 16, 2012
- Review
- 121 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K903134 (1991). 30 ancestors in all, the oldest K872291 (1987). 6 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
- 6 generations backK970211 Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics · 1998
- 5 generations backK013485 Microlife Upper Arm Automatic Blood Pressure Monitor, Model…Microlife Corp. · 2002
- 4 generations backK041411 Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004
- 3 generations backK060686 Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PCMicrolife Intellectual Property GmbH · 2006
- 2 generations backK081590 YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600…Ya Horng Electronic Co., Ltd. · 2008
- 1 generation backK083093 Cheetah ReliantCheetah Medical, Inc. · 2008 · Recalled
- This deviceK122129 Sphygmocor XcelAtcor Medical · 2012
- Descendant · cites it directly · 3 of its ownK151520 Oscar 2Suntech Medical, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK210139 Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06…Edan Instruments, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK251581 Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK251591 Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK221742 Conneqt PulseAtcor Medical · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K151520Oscar 2Suntech Medical, Inc. · 2016 · cites it directly3descendants
- K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09Edan Instruments, Inc. · 2021 · 2 generations on1descendant
- K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd. · 2026 · 2 generations on0descendants
- K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026 · 3 generations on0descendants
- K221742Conneqt PulseAtcor Medical · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K903134 | Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C | Omron Marshall Products, Inc. | 1991 | — |
| −6 | K970211 | Microlife Automatic Blood Pressure Monitor | Micro Weiss Electronics | 1998 | — |
| −5 | K013485 | Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with… | Microlife Corp. | 2002 | — |
| −4 | K041411 | Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP | Microlife Corp. | 2004 | — |
| −3 | K060686 | Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PC | Microlife Intellectual Property GmbH | 2006 | — |
| −2 | K081590 | YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R… | Ya Horng Electronic Co., Ltd. | 2008 | — |
| −1 | K083093 | Cheetah Reliant | Cheetah Medical, Inc. | 2008 | 1 |
| 0 (this device) | K122129 | Sphygmocor Xcel | Atcor Medical | 2012 | — |
| +1 | K151520 | Oscar 2 | Suntech Medical, Inc. | 2016 | 2 |
| +2 | K210139 | Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 | Edan Instruments, Inc. | 2021 | — |
| +2 | K251581 | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2026 | — |
| +3 | K251591 | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | 2026 | — |
| +1 | K221742 | Conneqt Pulse | Atcor Medical | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K070795 | Sphygmocor Cardiovascular Management SystemSummary page 2…to the operator. Technological Characteristics Comparison The SpiiygmoCor XCEL's Pulse Wave Analysis (PWA) feature is the same as the predicate SphygmoCor CvMS System (K070795) intechnological characteristics and intended use, except that it is uses a brachial arterial signal (captured via a brachial cuf… | 2007 |
| * | K080670 | Modification to Sphygmocor Cardiovascular Management SystemSummary page 2…is derived, the same software is used to calculate all parameters. The SphygmoCor XCEL's Pulse Wave Velocity (PW V) feature is the same as SphygnioCtr GyMS- PWV System (K080670) in technological characteristics and intended use, except measurement on the new device is a single step measurement due to the… | 2008 |
| * | K083093 | Cheetah ReliantSummary page 3…At or~ SphygmoCor XCEL - Traditional 510(k) Premnarket Notification The SphygmoCor XCEL's Non-Invasive Blood Pressure (NIBP) feature is the same as Cheetah Reliant (K083093) in technological characteristics and intended use. They both use the same 3rd party NIBP Module (SunTech Medical Advantage Mini… | 2008 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 30 ancestors has a recall of any class.
- Of its descendants, K151520 (Suntech Medical, Inc., 2016) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K070795.
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. 2012, 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 SphygmoCore XCEL System provides a derived ascending aortic blond pressure waveform and range of central arterial indices. These measurements are provided non-invasively through the use of a Brachial cuff.
It is to be used on those patients where information related to ascending aortic blood pressure is desired but the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.
Additionally, the SphygmoCoro XCEL System automatically measures Systolic blood pressure and Diastolic blood pressure. The SphygmoCore XCEL Pulse Wave Velocity (PWV) option is intended to obtain PWV measurements. The PWV option is used on adult patients only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122129 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122129: Sphygmocor Xcel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122129
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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