510(k) · Cleared
ClearedVP-2000/1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Colin Corp. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jul 9, 2002 as substantially equivalent to K921048 (Colin Medical Instruments Corp., 1993) and 4 other predicates after a 266-day review. Its family tree reaches back 2 generations to 1987. 46 later devices descend from it.
- Decided
- Jul 9, 2002
- Review
- 266 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K872291 (1987). 8 ancestors in all. 46 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK872291 Escort Portable Patient MonitorMedical Data Electronics · 1987
- 1 generation backK973637 Press-Mate AdvantageColin Medical Instruments Corp. · 1998
- This deviceK013434 VP-2000/1000Colin Corp. · 2002
- Descendant · cites it directly · 27 of its ownK082357 Microlife Upper Arm Automatic Digital Blood Pressure Monitor…Microlife Intellectual Property GmbH · 2008
- Descendant · 2 generations on · 15 of its ownK151869 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland · 2015
- Descendant · 3 generations on · 12 of its ownK153077 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2016
- Descendant · cites it directly · 8 of its ownK080670 Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical · 2008
- Descendant · 2 generations on · 6 of its ownK122129 Sphygmocor XcelAtcor Medical · 2012
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K082357Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office…Microlife Intellectual Property GmbH · 2008 · cites it directly27descendants
- K151869Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland · 2015 · 2 generations on15descendants
- K153077Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2016 · 3 generations on12descendants
- K080670Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical · 2008 · cites it directly8descendants
- K122129Sphygmocor XcelAtcor Medical · 2012 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K872291 | Escort Portable Patient Monitor | Medical Data Electronics | 1987 | — |
| −1 | K973637 | Press-Mate Advantage | Colin Medical Instruments Corp. | 1998 | — |
| 0 (this device) | K013434 | VP-2000/1000 | Colin Corp. | 2002 | — |
| +1 | K082357 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp… | Microlife Intellectual Property GmbH | 2008 | — |
| +2 | K151869 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH, Switzerland | 2015 | — |
| +3 | K153077 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2016 | — |
| +1 | K080670 | Modification to Sphygmocor Cardiovascular Management System | Atcor Medical | 2008 | — |
| +2 | K122129 | Sphygmocor Xcel | Atcor Medical | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 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? (5)
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 |
|---|---|---|---|
| * | K921048 | BP8800T/8000IR/8300G Non-Invasive Blood Pres. SystSummary page 1…l of these devices were reviewed by the Cardiovascular Devices Panel. 1 3. Predicate Devices Press-Mate BP8800 (510k # K 921048) ' Press-Mate Advantage ( 5 1Ok # K973637) IMEXLAB 9100 (510k # K973562) PILOT 9200 ( 5 10k # K922668) CADIsc… | 1993 |
| * | K973637 | Press-Mate AdvantageSummary page 1…scular Devices Panel. 1 3. Predicate Devices Press-Mate BP8800 (510k # K 921048) ' Press-Mate Advantage ( 5 1Ok # K973637) IMEXLAB 9100 (510k # K973562) PILOT 9200 ( 5 10k # K922668) CADIscope ( 5 10k # K990809) 4. Device Description… | 1998 |
| * | K973562 | Imex Medical Systems, Inc. Imexlab 9100Summary page 1…1 3. Predicate Devices Press-Mate BP8800 (510k # K 921048) ' Press-Mate Advantage ( 5 1Ok # K973637) IMEXLAB 9100 (510k # K973562) PILOT 9200 ( 5 10k # K922668) CADIscope ( 5 10k # K990809) 4. Device Description The BP-203 W E I1 Series VP-… | 1998 |
| * | K922668 | Pilot Model 9200 Blood Pressure Measurement SystemSummary page 1…Predicate Devices Press-Mate BP8800 (510k # K 921048) ' Press-Mate Advantage ( 5 1Ok # K973637) IMEXLAB 9100 (510k # K973562) PILOT 9200 ( 5 10k # K922668) CADIscope ( 5 10k # K990809) 4. Device Description The BP-203 W E I1 Series VP-1000 and VP-2000 monitor is a presc… | 1997 |
| * | K990809 | Cadiscope Electronic StethoscopeSummary page 1…te BP8800 (510k # K 921048) ' Press-Mate Advantage ( 5 1Ok # K973637) IMEXLAB 9100 (510k # K973562) PILOT 9200 ( 5 10k # K922668) CADIscope ( 5 10k # K990809) 4. Device Description The BP-203 W E I1 Series VP-1000 and VP-2000 monitor is a prescriptive device intended for u… | 1999 |
What descends from it? (46)
See all 467 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082357 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office… | 2008 | 27 |
| K080670 | Modification to Sphygmocor Cardiovascular Management System | 2008 | 8 |
| K050233 | Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model Hem-9000AI | 2005 | 6 |
| K112845 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | 2011 | 3 |
| K222153 | Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) | 2023 | 0 |
| K112521 | Fukuda Denshi Vasera Model VS-1500 | 2011 | 0 |
| K093205 | Padcheck | 2010 | 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 15 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K082357 (Microlife Intellectual Property GmbH, 2008) has gone furthest, with 27 descendants of its own.
- 3 other devices also cite its predicate K921048.
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?
VP-2000/1000 is a non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases. It has a capability of measuring; non-invasive blood pressures, heart rate, pulse wave, and heart sound
It also has a capability of calculating AB1 (Ankle Brachial Index), Pulse Wave Velocity, and Augmentation Index.
The instrument is used in a vascular laboratory, clinic, hospital, doctor’s office, and other medical facilities where the non-invasive peripheral vascular test is conducted.
It is used on adult patients only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013434 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013434: VP-2000/1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013434
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026