510(k) Report

510(k) · Cleared

Cleared

Cambridge Heart CH 2000 Cardiac Diagnostic System

K981697510(k) TraditionalCleared Oct 14, 1998156-day reviewClass II21 CFR 870.2340

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cambridge Heart, Inc. · DPS Electrocardiograph

Cleared on Oct 14, 1998 after a 156-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it.

Decided
Oct 14, 1998
Review
156 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
0

10 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2002: 3 descendants cleared2001: 3 descendants cleared2009: 1 descendant cleared2005: 1 descendant cleared2010: 1 descendant cleared1995200020052010201520202025
  1. This deviceK981697 Cambridge Heart CH 2000 Cardiac Diagnostic SystemCambridge Heart, Inc. · 1998
  2. Descendant · cites it directly · 9 of its ownK983102 Cardiac Diagnostic System Model CH 2000Cambridge Heart, Inc. · 1999
  3. Descendant · 2 generations on · 6 of its ownK012206 Alternanas Processing System, CH 2000 Cardiac Diagnostic System…Cambridge Heart, Inc. · 2001
  4. Descendant · 3 generations on · 3 of its ownK013565 Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2001
  5. Descendant · 4 generations on · 2 of its ownK022149 Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2002
  6. Descendant · 5 generations on · 1 of its ownK050225 Heartwave II Cardiac Diagnostic SystemCambridge Heart, Inc. · 2005

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

1999: 12001: 32002: 32005: 12009: 12010: 1
1999high 3 (2001) · low 0 (2000)2026

Most influential descendants

Showing 5 of 10 · See all
  • K983102Cardiac Diagnostic System Model CH 2000Cambridge Heart, Inc. · 1999 · cites it directly9descendants
  • K012206Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave Alternans…Cambridge Heart, Inc. · 2001 · 2 generations on6descendants
  • K013565Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2001 · 3 generations on3descendants
  • K022149Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2002 · 4 generations on2descendants
  • K050225Heartwave II Cardiac Diagnostic SystemCambridge Heart, Inc. · 2005 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K981697Cambridge Heart CH 2000 Cardiac Diagnostic SystemCambridge Heart, Inc.1998—
+1K983102Cardiac Diagnostic System Model CH 2000Cambridge Heart, Inc.1999—
+2K012206Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave…Cambridge Heart, Inc.2001—
+3K013565Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc.2001—
+4K022149Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc.2002—
+5K050225Heartwave II Cardiac Diagnostic SystemCambridge Heart, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200130
200230
200510
200910
201010
FIG. 1 — Lineage of K981697, 1998–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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. #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (10)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K983102Cardiac Diagnostic System Model CH 2000Cambridge Heart, Inc.19999

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?

  • Of its descendants, K983102 (Cambridge Heart, Inc., 1999) has gone furthest, with 9 descendants of its own.

How does its category compare?

All DPS devices

DPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DPS

6in 2025

2007: 112008: 132009: 142010: 112011: 222012: 122013: 102014: 112015: 82016: 112017: 92018: 142019: 32020: 62021: 52022: 62023: 102024: 82025: 62026 (partial year): 6
2007high 22 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPS

163in 2025

2007: 87 days median2008: 31 days median2009: 84 days median2010: 104 days median2011: 154 days median2012: 117 days median2013: 134 days median2014: 253 days median2015: 178 days median2016: 229 days median2017: 177 days median2018: 221 days median2019: 178 days median2020: 224 days median2021: 135 days median2022: 244 days median2023: 236 days median2024: 260 days median2025: 163 days median2026 (partial year): 258 days median
2007high 260 (2024) · low 31 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DPS

3in 2025

2007: 22009: 12010: 22011: 12019: 92020: 22021: 12022: 12023: 32024: 4, 1 Class I2025: 32026 (partial year): 4
2007high 9 (2019) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DPS

55in 2025

2007: 92008: 172009: 142010: 212011: 1212012: 562013: 152014: 152015: 302016: 122017: 152018: 192019: 272020: 592021: 242022: 592023: 542024: 642025: 55
2007high 121 (2011) · low 9 (2007)2025

MAUDE reports naming product code DPS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007118729
20081331017
20091484114
201011104221
2011221541121
201212117056
201310134015
201411253015
20158178030
201611229012
20179177015
201814221019
20193178927
20206224259
20215135124
20226244159
202310236354
202482604 (1)64
20256163355
202662584—

What is it indicated for?

The CH 2000 is intended for the recording of electrocardiograms and vector cardiograms by a physician, or under the direction of a physician, at rest and during ECG stress testing. ECG stress testing is indicated for diagnostic and prognostic evaluation of patients with known or suspected cardiovascular disease.

The correlation of the alternans results with a specific clinical diagnosis or prognosis, when the alternans are not visually apparent on the standard ECG has not been clinically established.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Cambridge Heart, Inc.

17 FDA decisions under this applicant name. See the company

  • K100362Cambridge Heart OemCambridge Heart, Inc. · 2010
  • K050225Heartwave II Cardiac Diagnostic SystemCambridge Heart, Inc. · 2005
  • K022152Heartwave Alternans Processing System, Model ApsCambridge Heart, Inc. · 2002
  • K022149Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2002
  • K013564Modification to Heartwave Alternans Processing System, Model ApsCambridge Heart, Inc. · 2001

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https://510kreport.com/device/K981697 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981697: Cambridge Heart CH 2000 Cardiac Diagnostic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981697

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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