510(k) Report

510(k) · Cleared

Cleared

Heartwave Alternans Processing System, Aps

K010758510(k) SpecialCleared Apr 12, 200130-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 Apr 12, 2001 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
Apr 12, 2001
Review
30 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
0

6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2001: 2 descendants cleared2002: 2 descendants cleared2005: 1 descendant cleared2010: 1 descendant cleared200020052010201520202025
  1. This deviceK010758 Heartwave Alternans Processing System, ApsCambridge Heart, Inc. · 2001
  2. Descendant · cites it directly · 3 of its ownK013565 Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2001
  3. Descendant · 2 generations on · 2 of its ownK022149 Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc. · 2002
  4. Descendant · 3 generations on · 1 of its ownK050225 Heartwave II Cardiac Diagnostic SystemCambridge Heart, Inc. · 2005
  5. Descendant · cites it directly · 1 of its ownK013564 Modification to Heartwave Alternans Processing System, Model ApsCambridge Heart, Inc. · 2001
  6. 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

2001: 22002: 22005: 12010: 1
2001high 2 (2001) · low 0 (2003)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010758Heartwave Alternans Processing System, ApsCambridge Heart, Inc.2001—
+1K013565Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc.2001—
+2K022149Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc.2002—
+3K050225Heartwave II Cardiac Diagnostic SystemCambridge Heart, Inc.2005—
+1K013564Modification to Heartwave Alternans Processing System, Model ApsCambridge Heart, Inc.2001—
+4K100362Cambridge Heart OemCambridge Heart, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200120
200220
200510
201010
FIG. 1 — Lineage of K010758, 2001–2010Source: 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), 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K013565Cardiac Diagnostic System, Model CH2000Cambridge Heart, Inc.20013
K013564Modification to Heartwave Alternans Processing System, Model ApsCambridge Heart, Inc.20011

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, K013565 (Cambridge Heart, Inc., 2001) has gone furthest, with 3 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—

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/K010758 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010758: Heartwave Alternans Processing System, Aps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010758

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026