510(k) Report

510(k) · Cleared

Cleared

Micro-Induction 1000 System

K013615510(k) TraditionalCleared May 29, 2002205-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

Harbinger Medical, Inc. · DPS Electrocardiograph

Cleared on May 29, 2002 as substantially equivalent to K950018 (Cambridge Heart, Inc., 1996) and 5 other predicates after a 205-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.

Decided
May 29, 2002
Review
205 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
6

Its longest line of descent runs back 3 generations to K930806 (1994). 12 ancestors in all, the oldest K782079 (1979). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors1996: 2 other ancestors1998: 1 other ancestor1989: 1 other ancestor1982: 1 other ancestor1979: 2 other ancestors2009: 1 descendant clearedK930806 · Zymed Holter Scanner Model 2010 · Agilent Technologies · 1994K955015 · Zymed Holter Scanner Model 2010 · Zymed Medical Instrumentation · 1996K983102 · Cardiac Diagnostic System Model CH 2000 · Cambridge Heart, Inc. · 199919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 5 other ancestors 1 generation forward: 1 descendant K983102 · Cardiac Diagnostic System Model CH 2000 · Cambridge Heart, Inc. · 1999K955015 · Zymed Holter Scanner Model 2010 · Zymed Medical Instrumentation · 1996K930806 · Zymed Holter Scanner Model 2010 · Agilent Technologies · 19940
  1. Root · 3 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
  2. 2 generations backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
  3. 1 generation backK983102 Cardiac Diagnostic System Model CH 2000Cambridge Heart, Inc. · 1999
  4. This deviceK013615 Micro-Induction 1000 SystemHarbinger Medical, Inc. · 2002
  5. Descendant · cites it directly · 0 of its ownK090249 Modification to: Micro-Induction 1000 SystemHarbinger Medical, Inc. · 2009

Most influential descendants

Showing 1 of 1 · See all
  • K090249Modification to: Micro-Induction 1000 SystemHarbinger Medical, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K930806Zymed Holter Scanner Model 2010Agilent Technologies1994—
−2K955015Zymed Holter Scanner Model 2010Zymed Medical Instrumentation1996—
−1K983102Cardiac Diagnostic System Model CH 2000Cambridge Heart, Inc.1999—
0 (this device)K013615Micro-Induction 1000 SystemHarbinger Medical, Inc.2002—
+1K090249Modification to: Micro-Induction 1000 SystemHarbinger Medical, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197920
198210
198910
199620
199810
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
FIG. 1 — Lineage of K013615, 1994–2009Source: 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 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 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? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K950018Cambridge Heart CH 2000 Stress Test System
Summary page 1
…360 Product Codec DPS DRX Predicate Device(s): . The Micro-Induction 1>000 systee is substantially equivalent to the Cambridge Heart CH 2000 Cardiac Diagnostic System (K950018 — K933102 — K001034), and the Canobridge Heart Micro-V Alternans Seasor (K00223¢) and Cambridge Heart Hi-Res ECG Electrode (K9621…
Cambridge Heart, Inc.1996—
*K983102Cardiac Diagnostic System Model CH 2000
Summary page 2
…he United States and one site in Europe. The Micro-Induction 1000 system is substantially equivalent to the Cambridge Heart CH 2000 Cardiac Diagnostic System (K950018 — K983102 — K001034) and the Cambridge Heart Micro-V Alternans Sensor (K002230) and Cambridge Heart Hi-Res ECG Electrode (K962113) all manu…
Cambridge Heart, Inc.1999—
*K001034Model Aps Alternans Processing System
Summary page 1
…S DRX Predicate Device(s): . The Micro-Induction 1>000 systee is substantially equivalent to the Cambridge Heart CH 2000 Cardiac Diagnostic System (K950018 — K933102 — K001034), and the Canobridge Heart Micro-V Alternans Seasor (K00223¢) and Cambridge Heart Hi-Res ECG Electrode (K962115) all manufactured…
Cambridge Heart, Inc.2000—
*K002230Cambridge Heart Micro-V Alternans Sensor, Model 20327-002
Summary page 2
…stem is substantially equivalent to the Cambridge Heart CH 2000 Cardiac Diagnostic System (K950018 — K983102 — K001034) and the Cambridge Heart Micro-V Alternans Sensor (K002230) and Cambridge Heart Hi-Res ECG Electrode (K962113) all manufactured by Cambridge Heart, Inc. Harbinger Medicsl also considers th…
Cambridge Heart, Inc.20001
*K962115Cambridge Heart HI-Res Ecg Electrode
Summary page 1
…rt CH 2000 Cardiac Diagnostic System (K950018 — K933102 — K001034), and the Canobridge Heart Micro-V Alternans Seasor (K00223¢) and Cambridge Heart Hi-Res ECG Electrode (K962115) all manufactured by Cambridge Heart, Inc. Harbinger Medical also considecs the MI 1000 to be substantially equivalent to the Zym…
Cambridge Heart, Inc.1996—
*K955015Zymed Holter Scanner Model 2010
Summary page 1
…e (K962115) all manufactured by Cambridge Heart, Inc. Harbinger Medical also considecs the MI 1000 to be substantially equivalent to the Zymed Model 2010 Holter Scanner (K955015), manufactured by Zymed, Inc., and other stnailar devices made by other manufacturers. Device Deseription: The device consists o…
Zymed Medical Instrumentation1996—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K090249Modification to: Micro-Induction 1000 SystemHarbinger Medical, Inc.20090

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 8 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
  • 1 of the 12 ancestors has a recall of any class.
  • Of its descendants, K090249 (Harbinger Medical, Inc., 2009) has gone furthest, with 0 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 MI-1000 is used to measure Wavelet Surface Residanm indices at rest and during low level electrical stimalation during the cardiac refractory periad. This data is peescated in 2 erapbical format far interpretation by 2 trained phiysician. The MI-1000 is akso used for the measurement of SAEOG indices. The MI-1000 should be used anly as & adjunct to clinical Iistory and fhe results of adber noaInvasive andfor Invasive tesés.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Harbinger Medical, Inc.

2 FDA decisions under this applicant name. See the company

  • K090249Modification to: Micro-Induction 1000 SystemHarbinger Medical, Inc. · 2009

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https://510kreport.com/device/K013615 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013615: Micro-Induction 1000 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013615

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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