510(k) · Cleared
ClearedAlternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave Alternans Processing System
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 Oct 12, 2001 as substantially equivalent to K983102 (Cambridge Heart, Inc., 1999) and 1 other predicate after a 91-day review. Its family tree reaches back 3 generations to 1994. 6 later devices descend from it.
- Decided
- Oct 12, 2001
- Review
- 91 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K930806 (1994). 5 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 2 generations backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- 1 generation backK983102 Cardiac Diagnostic System Model CH 2000Cambridge Heart, Inc. · 1999
- This deviceK012206 Alternanas Processing System, CH 2000 Cardiac Diagnostic System…Cambridge Heart, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK013565 Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2001
- Descendant · 2 generations on · 2 of its ownK022149 Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2002
- Descendant · 3 generations on · 1 of its ownK050225 Heartwave II Cardiac Diagnostic SystemCambridge Heart, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK013564 Modification to Heartwave Alternans Processing System, Model ApsCambridge Heart, Inc. · 2001
- Descendant · 4 generations on · 0 of its ownK100362 Cambridge Heart OemCambridge Heart, Inc. · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K013565Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2001 · cites it directly3descendants
- K022149Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2002 · 2 generations on2descendants
- K050225Heartwave II Cardiac Diagnostic SystemCambridge Heart, Inc. · 2005 · 3 generations on1descendant
- K013564Modification to Heartwave Alternans Processing System, Model ApsCambridge Heart, Inc. · 2001 · cites it directly1descendant
- K100362Cambridge Heart OemCambridge Heart, Inc. · 2010 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −2 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| −1 | K983102 | Cardiac Diagnostic System Model CH 2000 | Cambridge Heart, Inc. | 1999 | — |
| 0 (this device) | K012206 | Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave… | Cambridge Heart, Inc. | 2001 | — |
| +1 | K013565 | Cardiac Diagnostic System, Model CH2000 | Cambridge Heart, Inc. | 2001 | — |
| +2 | K022149 | Cardiac Diagnostic System, Model CH2000 | Cambridge Heart, Inc. | 2002 | — |
| +3 | K050225 | Heartwave II Cardiac Diagnostic System | Cambridge Heart, Inc. | 2005 | — |
| +1 | K013564 | Modification to Heartwave Alternans Processing System, Model Aps | Cambridge Heart, Inc. | 2001 | — |
| +4 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 2 | 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 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 26.6 · 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 |
|---|---|---|---|
| * | K983102 | Cardiac Diagnostic System Model CH 2000Summary page 1…-8431 Contact: David Chazanovitz 510(k) Numbers and Product Codes of equivalent devices. Cambridge Heart, Inc.; Model CH 2000 Cardiac Diagnostic System 510(k) Number: #K983102 Product Code: 74 DPS CFR Section: 870.2340 Spacelabs/Burdick, Inc.; Quest Exercise Stress system 510(k) Number: #K952417 Product… | 1999 |
| * | K952417 | Quest Exercise Stress SystemSummary page 1…H 2000 Cardiac Diagnostic System 510(k) Number: #K983102 Product Code: 74 DPS CFR Section: 870.2340 Spacelabs/Burdick, Inc.; Quest Exercise Stress system 510(k) Number: #K952417 Product Code: 74 DSI CFR Section: 870.1025 Indications for Use and Intended Population Indications for use The Alternans Proces… | 1996 |
| † | K962115 | Cambridge Heart HI-Res Ecg Electrode | 1996 |
| † | K002230 | Cambridge Heart Micro-V Alternans Sensor, Model 20327-002 | 2000 |
What descends from it? (6)
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 7 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K013565 (Cambridge Heart, Inc., 2001) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K983102.
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 Alternans Processing System is intended for the 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 Alternans Processing 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 Alternans Processing System…
Read the full statement (205 words)
The Alternans Processing System is intended for the 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 Alternans Processing 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 Alternans Processing 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 present in 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/K012206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012206: Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave Alternans Processing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012206
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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