510(k) Report

510(k) · Cleared

Cleared

Portable, Electrocardiograph (Ecg) Monitor, Model HCG-801

K060766510(k) TraditionalCleared Jun 9, 200679-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

Omron Healthcare, Inc. · DPS Electrocardiograph

Cleared on Jun 9, 2006 as substantially equivalent to K992696 (Card Guard Scientific Survival, Ltd., 1999) after a 79-day review. Its family tree reaches back 1 generation to 1999. 55 later devices descend from it.

Decided
Jun 9, 2006
Review
79 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K992696 (1999). 55 later devices descend from it, 11 citing it directly.

Descendants, by year cleared 2008: 3 descendants cleared2007: 2 descendants cleared2013: 2 descendants cleared2010: 1 descendant cleared2011: 5 descendants cleared2015: 2 descendants cleared2009: 1 descendant cleared2012: 1 descendant cleared2017: 4 descendants cleared2018: 3 descendants cleared2019: 4 descendants cleared2021: 2 descendants cleared2022: 5 descendants cleared2020: 1 descendant cleared2023: 3 descendants cleared2024: 6 descendants cleared2025: 5 descendants cleared2026: 5 descendants clearedK992696 · Ecg Minimonitor, Model CG-5000 · Card Guard Scientific Survival, Ltd. · 19991995200020052010201520202025
Descendants, by generation 1 generation forward: 11 descendants2 generations forward: 7 descendants3 generations forward: 5 descendants4 generations forward: 11 descendants5 generations forward: 7 descendants6 generations forward: 4 descendants7 generations forward: 4 descendants8 generations forward: 4 descendants9 generations forward: 2 descendants K992696 · Ecg Minimonitor, Model CG-5000 · Card Guard Scientific Survival, Ltd. · 19990+5
  1. Root · 1 generation backK992696 Ecg Minimonitor, Model CG-5000Card Guard Scientific Survival, Ltd. · 1999
  2. This deviceK060766 Portable, Electrocardiograph (Ecg) Monitor, Model HCG-801Omron Healthcare, Inc. · 2006
  3. Descendant · cites it directly · 37 of its ownK093872 Handheld Ecg Monitor, Model MD100Beijing Choice Electronic Technololgy Co., Ltd. · 2010
  4. Descendant · cites it directly · 32 of its ownK111438 REKA E100Reka Pte, Ltd. · 2011
  5. Descendant · 2 generations on · 31 of its ownK121628 Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013
  6. Descendant · 3 generations on · 30 of its ownK143513 ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015
  7. Descendant · 4 generations on · 18 of its ownK163512 Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · Recalled

Showing 5 of 55 descendants. See all descendants

Descendants cleared per year

2007: 22008: 32009: 12010: 12011: 52012: 12013: 22015: 22017: 42018: 32019: 42020: 12021: 22022: 52023: 32024: 62025: 52026: 5
2007high 6 (2024) · low 0 (2014)2026

Most influential descendants

Showing 5 of 55 · See all
  • K093872Handheld Ecg Monitor, Model MD100Beijing Choice Electronic Technololgy Co., Ltd. · 2010 · cites it directly37descendants
  • K111438REKA E100Reka Pte, Ltd. · 2011 · cites it directly32descendants
  • K121628Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013 · 2 generations on31descendants
  • K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015 · 3 generations on30descendants
  • K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · 4 generations on18descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K992696Ecg Minimonitor, Model CG-5000Card Guard Scientific Survival, Ltd.1999—
0 (this device)K060766Portable, Electrocardiograph (Ecg) Monitor, Model HCG-801Omron Healthcare, Inc.2006—
+1K093872Handheld Ecg Monitor, Model MD100Beijing Choice Electronic Technololgy Co., Ltd.2010—
+1K111438REKA E100Reka Pte, Ltd.2011—
+2K121628Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd.2013—
+3K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc.2015—
+4K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.20171

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200830
200910
201010
201150
201210
201320
201520
201740
201830
201940
202010
202120
202250
202330
202460
202550
202650
FIG. 1 — Lineage of K060766, 1999–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K992696Ecg Minimonitor, Model CG-5000
Summary page 1
…Class II Device: Omron HCG-801 Portable EGG Monitor Predicate Devices: GG 5000 EGG Mini Monitor Transmitter K992696 DeviceiDescription: The Omron HCG-801 portable EGG Monitor is activated by the user whenever symptoms (palpitations, skipped be…
Card Guard Scientific Survival, Ltd.1999—

What descends from it? (55)

See all 55

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

NumberDeviceApplicantDecidedDescendants
K093872Handheld Ecg Monitor, Model MD100Beijing Choice Electronic Technololgy Co., Ltd.201037
K111438REKA E100Reka Pte, Ltd.201132
K062894Instantcheck RTD-Ecg Monitor, Model RMH4.0Dailycare Biomedical, Inc.20076
K101569V-Trust Model TD-2202 Portable Ecg RecorderTaidoc Technology Corporation20112
K082013Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin20081
K080933Handheld Ecg Monitor, Model MD100Beijing Choice Electronic Technololgy Co., Ltd.20081
K131572Micro Ambulatory Ecg RecorderDimetek Digital Medical Technologies, Ltd.20130
K110328Acg-8511 Portable Ecg MonitorAndon Health Co, Ltd.20110
K103077Ecg PenMeridian Dynamics Biomedical, Inc.20110
K073152PC-180 / Prince 180 Easy Ecg MonitorShenzhen Creative Industry Co., Ltd.20080

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?

  • Its one ancestor has no recall.
  • Of its descendants, K093872 (Beijing Choice Electronic Technololgy Co., Ltd., 2010) has gone furthest, with 37 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 Omron HCG-801 portable ECG Monitor is intended for

recording and displaying ECG data by adult patients who are concerned about their heart

rhythm. This Omron HCG-801 portable ECG Monitor allows the consumer to record

their ECG data into the device memory for display by healthcare professionals during

office visits.

Specifically, Omron HCG-801 portable ECG Monitor is intended for adult

patients who are concerned about their heart rhythm or have experienced the

following symptoms that are suggestive of abnormal heart rhythm:

-Skipped beats

-Pounding heart (palpitations)

-History of arrhythmia

Indications for use as stated in the FDA summary.

More from Omron Healthcare, Inc.

68 FDA decisions under this applicant name. See the company

  • DEN230076Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ))…Omron Healthcare, Inc. · 2024
  • K202228Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc. · 2021
  • K183215Focus TENS Therapy, Model PM710-M/-LOmron Healthcare, Inc. · 2019
  • K190693HEM-6410T-ZL Wrist Blood Pressure MonitorOmron Healthcare, Inc. · 2019
  • K182579Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc. · 2019

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https://510kreport.com/device/K060766 · printed Nov 5, 2026

Cite this page

510(k) Report. “K060766: Portable, Electrocardiograph (Ecg) Monitor, Model HCG-801.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060766

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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