510(k) · Cleared
ClearedCardiac Diagnostic System, Model CH2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cambridge Heart, Inc. · DPS Electrocardiograph
Cleared on Nov 21, 2001 as substantially equivalent to K010758 (Cambridge Heart, Inc., 2001) and 2 other predicates after a 26-day review. Its family tree reaches back 4 generations to 1994. 3 later devices descend from it.
- Decided
- Nov 21, 2001
- Review
- 26 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K930806 (1994). 8 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 3 generations backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- 2 generations backK983102 Cardiac Diagnostic System Model CH 2000Cambridge Heart, Inc. · 1999
- 1 generation backK012206 Alternanas Processing System, CH 2000 Cardiac Diagnostic System…Cambridge Heart, Inc. · 2001
- This deviceK013565 Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK022149 Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK050225 Heartwave II Cardiac Diagnostic SystemCambridge Heart, Inc. · 2005
- Descendant · 3 generations on · 0 of its ownK100362 Cambridge Heart OemCambridge Heart, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −3 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| −2 | K983102 | Cardiac Diagnostic System Model CH 2000 | Cambridge Heart, Inc. | 1999 | — |
| −1 | K012206 | Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave… | Cambridge Heart, Inc. | 2001 | — |
| 0 (this device) | K013565 | Cardiac Diagnostic System, Model CH2000 | Cambridge Heart, Inc. | 2001 | — |
| +1 | K022149 | Cardiac Diagnostic System, Model CH2000 | Cambridge Heart, Inc. | 2002 | — |
| +2 | K050225 | Heartwave II Cardiac Diagnostic System | Cambridge Heart, Inc. | 2005 | — |
| +3 | K100362 | Cambridge Heart Oem | Cambridge Heart, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 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 DPS? 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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 |
|---|---|---|---|
| * | K010758 | Heartwave Alternans Processing System, ApsSummary page 1…275-8431 (Fax) Contact: David Chazanovitz 510(k) Numbers and Product Codes of equivalent devices. Cambridge Heart Heartwave™ Alternans Processing System 510K Number; #K010758 Product Code: 74 DPS CFR Section: 870.2340 Cambridge Heart Model CH 2000 Cardiac Diagnostic System 510K Number; #K010756 Produc… | 2001 |
| * | K010756 | CH 2000 Cardiac Diagnostic SystemSummary page 1…ve™ Alternans Processing System 510K Number; #K010758 Product Code: 74 DPS CFR Section: 870.2340 Cambridge Heart Model CH 2000 Cardiac Diagnostic System 510K Number; #K010756 Product Code: 74 DPS CFR Section: 870.2340 Cambridge Heart Alternans Processing System 510K Number; #K012206 Product Code: 74 D… | 2001 |
| * | K012206 | Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave Alternans…Summary page 1…eart Model CH 2000 Cardiac Diagnostic System 510K Number; #K010756 Product Code: 74 DPS CFR Section: 870.2340 Cambridge Heart Alternans Processing System 510K Number; #K012206 Product Code: 74 DPS CFR Section: 870.2340 Indications for Use and intended Population The Model CH 2000 Cardiac Diagnostic Sy… | 2001 |
| † | K002230 | Cambridge Heart Micro-V Alternans Sensor, Model 20327-002 | 2000 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022149 | Cardiac Diagnostic System, Model CH2000 | 2002 | 2 |
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 7 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K022149 (Cambridge Heart, Inc., 2002) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K010758.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
The Model CH 2000 Cardiac Diagnostic System is intended for the recording of electrocardiograms, vector cardiograms and measurement of Microvolt T-Wave Alternans* at rest and during ECG stress testing. The presence of Microvolt T-wave Alternans as measured by the Analytic Spectral Method of the Model CH2000 Cardiac Diagnostic System in patients with known, suspected or at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event…
Read the full statement (217 words)
The Model CH 2000 Cardiac Diagnostic System is intended for the
recording of electrocardiograms, vector cardiograms and measurement
of Microvolt T-Wave Alternans* at rest and during ECG stress testing.
The presence of Microvolt T-wave Alternans as measured by the
Analytic Spectral Method of the Model CH2000 Cardiac Diagnostic
System in patients with known, suspected or at risk of ventricular
tachyarrhythmia predicts increased risk of a cardiac event (ventricular
tachyarrhythmia or sudden death).
The Model CH2000 Cardiac Diagnostic System should be used only as
an adjunct to clinical history and the results of other non-invasive and/or
invasive tests. The interpretive results of the Alternans Processing
System should be reviewed by a qualified physician.
The predictive value of T-wave Alternans for cardiac events has not
been established in patients with active, untreated ischemia.
*Microvolt T-wave Alternans is defined as T-wave alternans which
(a) is measured from high-resolution multi-segment sensors, (b) is
presentin leads X, Y, Z, VM or two adjacent precordial leads, (c) is
at the level of 1.9 microvolts after signal optimization and
subtraction of the background noise level, (d) is at least three
standard deviations greater than the background noise level, (e)
has an onset heart rate at or below 110 beats per minute, and (f) is
sustained for all heart rates above the onset heart rate.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013565 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013565: Cardiac Diagnostic System, Model CH2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013565
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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