510(k) · Cleared
ClearedCambridge Heart Oem
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 14, 2010 as substantially equivalent to K050225 (Cambridge Heart, Inc., 2005) after a 61-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Apr 14, 2010
- Review
- 61 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K930806 (1994). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 6 generations backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- 5 generations backK983102 Cardiac Diagnostic System Model CH 2000Cambridge Heart, Inc. · 1999
- 4 generations backK012206 Alternanas Processing System, CH 2000 Cardiac Diagnostic System…Cambridge Heart, Inc. · 2001
- 3 generations backK013565 Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2001
- 2 generations backK022149 Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2002
- 1 generation backK050225 Heartwave II Cardiac Diagnostic SystemCambridge Heart, Inc. · 2005
- This deviceK100362 Cambridge Heart OemCambridge Heart, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −6 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| −5 | K983102 | Cardiac Diagnostic System Model CH 2000 | Cambridge Heart, Inc. | 1999 | — |
| −4 | K012206 | Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave… | Cambridge Heart, Inc. | 2001 | — |
| −3 | K013565 | Cardiac Diagnostic System, Model CH2000 | Cambridge Heart, Inc. | 2001 | — |
| −2 | K022149 | Cardiac Diagnostic System, Model CH2000 | Cambridge Heart, Inc. | 2002 | — |
| −1 | K050225 | Heartwave II Cardiac Diagnostic System | Cambridge Heart, Inc. | 2005 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K050225 | Heartwave II Cardiac Diagnostic SystemSummary page 1…k) Numbers and Product Codes of equivalent devices: Cambridge Heart, Inc.; HearTwave 1ICardiac Diagnostic System 510(k) Number: # K050225 Product Code: 74 DPS CFR Section: 870.2340 Indications for Use and Intended Popul… | 2005 |
| † | K962115 | Cambridge Heart HI-Res Ecg Electrode | 1996 |
| † | K002230 | Cambridge Heart Micro-V Alternans Sensor, Model 20327-002 | 2000 |
| † | K983012 | Unnamed device | |
| † | K001034 | Model Aps Alternans Processing System | 2000 |
| † | K003492 | Analytic Spectral Method of Alternans Processing; CH 2000 Cardiac Diagnostic System… | 2001 |
| † | K022149 | Cardiac Diagnostic System, Model CH2000 | 2002 |
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 16 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 11 ancestors has a recall.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 Cambridge Heart MTWA OEM Module 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 MTWA OEM Module in patients with known, suspected or at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or…
Read the full statement (213 words)
The Cambridge Heart MTWA OEM Module 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 MTWA OEM Module in patients with known, suspected or at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death).
The MTWA OEM Module 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 MTWA OEM Module 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 as stated in the FDA summary.
https://510kreport.com/device/K100362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100362: Cambridge Heart Oem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100362
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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