510(k) Report

510(k) · Cleared

Cleared

Intelwave Heart Rate Variability System, Version 1.0

K062068510(k) TraditionalCleared Oct 27, 200698-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

Intelwave, LLC · DPS Electrocardiograph

Cleared on Oct 27, 2006 as substantially equivalent to K010955 (Boston Medical Technologies, Inc., 2001) and 3 other predicates after a 98-day review. Its family tree reaches back 3 generations to 1992. 1 later device descends from it.

Decided
Oct 27, 2006
Review
98 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K922171 (1992). 12 ancestors in all, the oldest K881905 (1988). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2001: 2 other ancestors1995: 3 other ancestors2000: 1 other ancestor1988: 2 other ancestors2015: 1 descendant clearedK922171 · Centra II Analysis System · Marquette Electronics, Inc. · 1992K991786 · Mars Unity Workstation with Heart Rate Variability (HRV) Option · General Electric Medical Systems Information Techn · 1999K021230 · HERO · Medical Decision Networks · 20031990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 5 other ancestors3 generations back: 1 other ancestor 1 generation forward: 1 descendant K021230 · HERO · Medical Decision Networks · 2003K991786 · Mars Unity Workstation with Heart Rate Variability (HRV) Option · General Electric Medical Systems Information Techn · 1999K922171 · Centra II Analysis System · Marquette Electronics, Inc. · 19920
  1. Root · 3 generations backK922171 Centra II Analysis SystemMarquette Electronics, Inc. · 1992
  2. 2 generations backK991786 Mars Unity Workstation with Heart Rate Variability (HRV) OptionGeneral Electric Medical Systems Information Techn · 1999
  3. 1 generation backK021230 HEROMedical Decision Networks · 2003
  4. This deviceK062068 Intelwave Heart Rate Variability System, Version 1.0Intelwave, LLC · 2006
  5. Descendant · cites it directly · 0 of its ownK142551 QANS (Quantitative Autonomic Nervous System) Monitoring SystemHhssystems, LLC · 2015

Most influential descendants

Showing 1 of 1 · See all
  • K142551QANS (Quantitative Autonomic Nervous System) Monitoring SystemHhssystems, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K922171Centra II Analysis SystemMarquette Electronics, Inc.1992—
−2K991786Mars Unity Workstation with Heart Rate Variability (HRV) OptionGeneral Electric Medical Systems Information Techn1999—
−1K021230HEROMedical Decision Networks2003—
0 (this device)K062068Intelwave Heart Rate Variability System, Version 1.0Intelwave, LLC2006—
+1K142551QANS (Quantitative Autonomic Nervous System) Monitoring SystemHhssystems, LLC2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198820
199530
200010
200120
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K062068, 1992–2015Source: 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? (4)

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
*K010955BMT Anscore Health Management System
Summary page 1
…3. Predicate device. Intelwave 1.0 system is substantially equivalent to the following predicate devices: 1. Anscore TM Health Management System (510(k) K010955). 2. Holter PlusTM Ambulatory ECG Analysis System (510(k) K042463). 3. ANX 3.0 Respiratory and cardiac spectral frequen…
Boston Medical Technologies, Inc.2001—
*K042463Holter Plus
Summary page 1
…alent to the following predicate devices: 1. Anscore TM Health Management System (510(k) K010955). 2. Holter PlusTM Ambulatory ECG Analysis System (510(k) K042463). 3. ANX 3.0 Respiratory and cardiac spectral frequency signal (510(k) K941252). 4. HeRO TM HRV analysis syste…
Rozinn Electronics, Inc.2004—
*K941252Respiratory and Cardiac Spectral Frequency Signal Processor
Summary page 1
…10(k) K010955). 2. Holter PlusTM Ambulatory ECG Analysis System (510(k) K042463). 3. ANX 3.0 Respiratory and cardiac spectral frequency signal (510(k) K941252). 4. HeRO TM HRV analysis system (510(k) K021230). CONFIDENTIAL 3/07/2006 PRE…
Ansar19951
*K021230HERO
Summary page 1
…nalysis System (510(k) K042463). 3. ANX 3.0 Respiratory and cardiac spectral frequency signal (510(k) K941252). 4. HeRO TM HRV analysis system (510(k) K021230). CONFIDENTIAL 3/07/2006 PREMARKET NOTIFICATION 510(k)…
Medical Decision Networks2003—

Also cleared against K010955: 2 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K142551QANS (Quantitative Autonomic Nervous System) Monitoring SystemHhssystems, LLC20150

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 14 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
  • 1 of the 12 ancestors has a recall of any class.
  • Of its descendants, K142551 (Hhssystems, LLC, 2015) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K010955.

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 Intelwave 1.0 System is intended for use in Heart Rate Variability (HRV) measurements in response to paced respiration and controlled exercises.

Indications for use as stated in the FDA summary.

Also cleared against K010955

2 other devices cite the same predicate.

  • K080884QHRV 1 - Health Assessment SystemMedtechs, LLC · 2008
  • K070795Sphygmocor Cardiovascular Management SystemAtcor Medical Pty, Ltd. · 2007

Recent decisions in DPS

The DPS category page

  • K260640Kinetic Software LibraryMonebo Technologies, Inc. · 2026
  • K260005MyoVista wavECG (DG-200-B15-003)HeartSciences, Inc. · 2026
  • K260250QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)QT Medical, Inc. · 2026
  • K254255S-Patch CardioAIWellysis Corp. · 2026
  • K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc. · 2026

https://510kreport.com/device/K062068 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062068: Intelwave Heart Rate Variability System, Version 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062068

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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