510(k) · Cleared
ClearedCardioscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulsecor Limited · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Dec 11, 2012 as substantially equivalent to K101002 (Healthstats International Pte., Ltd., 2010) and 2 other predicates after a 229-day review. Its family tree reaches back 6 generations to 1987.
- Decided
- Dec 11, 2012
- Review
- 229 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K872291 (1987). 31 ancestors in all, the oldest K855127 (1986). No later device cites it as a predicate yet.
- Root · 6 generations backK872291 Escort Portable Patient MonitorMedical Data Electronics · 1987
- 5 generations backK973637 Press-Mate AdvantageColin Medical Instruments Corp. · 1998
- 4 generations backK013434 VP-2000/1000Colin Corp. · 2002
- 3 generations backK050233 Omron Non-Invasive Blood Pressure Monitor with Augmentation Index…Omron Healthcare, Inc. · 2005
- 2 generations backK072593 A-Plus Arterial Pulse Waveform Analysis System and PC SoftwareHealthstats International Pte., Ltd. · 2007
- 1 generation backK101002 A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200Healthstats International Pte., Ltd. · 2010
- This deviceK121266 CardioscopePulsecor Limited · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K872291 | Escort Portable Patient Monitor | Medical Data Electronics | 1987 | — |
| −5 | K973637 | Press-Mate Advantage | Colin Medical Instruments Corp. | 1998 | — |
| −4 | K013434 | VP-2000/1000 | Colin Corp. | 2002 | — |
| −3 | K050233 | Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model… | Omron Healthcare, Inc. | 2005 | — |
| −2 | K072593 | A-Plus Arterial Pulse Waveform Analysis System and PC Software | Healthstats International Pte., Ltd. | 2007 | — |
| −1 | K101002 | A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200 | Healthstats International Pte., Ltd. | 2010 | — |
| 0 (this device) | K121266 | Cardioscope | Pulsecor Limited | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2011 | 1 | 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 |
|---|---|---|---|
| * | K101002 | A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200Summary page 1…of Cardiovascular Devices 1. Predicate Devices HealthSTATS International Pte Ltd. A-PULSE CASPro and A-PULSE K101002 CASPaI Monitors AtCor Medical Pty Ltd. SphygmoCo… | 2010 |
| * | K012487 | Sphygmocor PX Model Scor-PXSummary page 1…A-PULSE K101002 CASPaI Monitors AtCor Medical Pty Ltd. SphygmoCor Px K012487 I.E.M. GmbH Mobil-O-Graph 24h PWA and K(110603… | 2002 |
| * | K110603 | Hypertension Management Software Claient Server (HMS-CS)Summary page 1…s AtCor Medical Pty Ltd. SphygmoCor Px K012487 I.E.M. GmbH Mobil-O-Graph 24h PWA and K(110603 Hypertension Management Software… | 2011 |
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 25 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- None of the 31 ancestors has a recall.
- 1 other device also cites its predicate K101002.
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?
CardioScopeTM is a non-invasive, compact standalone measurement device that automatically measures systolic and diastolic pressure, and pulse rate in adult and pediatric patients. CardioScope also provides non-invasive central (aortic) systolic, mean and diastolic blood pressure, and pulse waveform intended for use in adult patients.
CardioScope performs measurements using a conventional oscillometric method via a brachial cuff on the upper arm.
The device is intended to be used under supervision by qualified healthcare personnel.
Caution: Federal (USA) law restricts this device to sale by or on order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121266: Cardioscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121266
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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