510(k) · Cleared
ClearedCardiac Diagnostic System Model CH 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cambridge Heart, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Apr 12, 1999 as substantially equivalent to K981697 (Cambridge Heart, Inc., 1998) and 1 other predicate after a 221-day review. Its family tree reaches back 2 generations to 1994. 9 later devices descend from it.
- Decided
- Apr 12, 1999
- Review
- 221 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K930806 (1994). 3 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 1 generation backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- This deviceK983102 Cardiac Diagnostic System Model CH 2000Cambridge Heart, Inc. · 1999
- Descendant · cites it directly · 6 of its ownK012206 Alternanas Processing System, CH 2000 Cardiac Diagnostic System…Cambridge Heart, Inc. · 2001
- Descendant · 2 generations on · 3 of its ownK013565 Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2001
- Descendant · 3 generations on · 2 of its ownK022149 Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2002
- Descendant · 4 generations on · 1 of its ownK050225 Heartwave II Cardiac Diagnostic SystemCambridge Heart, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK013615 Micro-Induction 1000 SystemHarbinger Medical, Inc. · 2002
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K012206Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave Alternans…Cambridge Heart, Inc. · 2001 · cites it directly6descendants
- K013565Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2001 · 2 generations on3descendants
- K022149Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2002 · 3 generations on2descendants
- K050225Heartwave II Cardiac Diagnostic SystemCambridge Heart, Inc. · 2005 · 4 generations on1descendant
- K013615Micro-Induction 1000 SystemHarbinger Medical, Inc. · 2002 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −1 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| 0 (this device) | 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 | — |
| +2 | K013565 | Cardiac Diagnostic System, Model CH2000 | Cambridge Heart, Inc. | 2001 | — |
| +3 | K022149 | Cardiac Diagnostic System, Model CH2000 | Cambridge Heart, Inc. | 2002 | — |
| +4 | K050225 | Heartwave II Cardiac Diagnostic System | Cambridge Heart, Inc. | 2005 | — |
| +1 | K013615 | Micro-Induction 1000 System | Harbinger Medical, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
| 2009 | 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 DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 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 |
|---|---|---|---|
| * | K981697 | Cambridge Heart CH 2000 Cardiac Diagnostic System Cleared while this submission was under review Summary page 1…at rest and during ECG stress testing. It is substantially equivalent to: e Cambridge Heart Model CH 2000 (Cambridge Heart, Inc. Bedford, Mass). Premarket Notification K981697 In addition the alternans option is equivalent to: e Zymed Model 2010 Holter Scanner ( Zymed, Inc.) Pre-market Notification K95… | 1998 |
| * | K955015 | Zymed Holter Scanner Model 2010Summary page 1…ations For Use and Promotional Claims for the Cambridge Heart CH 2000 Cardiac Diagnostic System. The CH 2000 (K950018) and Zymed Model 2010 Holter Scanner (Zymed, Inc.) (K955015) contain data supporting a Substantial Equivalence determination. 1. General The Cambridge Heart CH 2000 with Alternans Option… | 1996 |
| † | K950018 | Cambridge Heart CH 2000 Stress Test System | 1996 |
| † | K962115 | Cambridge Heart HI-Res Ecg Electrode | 1996 |
What descends from it? (9)
2 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 5 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K012206 (Cambridge Heart, Inc., 2001) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
The CH 2000 is intended for the measurement of T-wave alternans and recording of electrocardiograms and vector cardiograms at rest and during ECG stress testing. The presence of T-wave alternans in patients with known, suspected or at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death).
The CH 2000 should be used only as an adjunct to clinical history and the results of other non-invasive and/or invasive tests.
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/K983102 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983102: Cardiac Diagnostic System Model CH 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983102
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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