510(k) Report

510(k) · Cleared

Cleared

Palm Ecg Recorder, Model EP-201/202

K061123510(k) TraditionalCleared Jun 29, 2007431-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

Parama-Tech Company., Ltd. · DPS Electrocardiograph

Cleared on Jun 29, 2007 as substantially equivalent to K042814 (Dailycare Biomedical, Inc., 2005) and 1 other predicate after a 431-day review. Its family tree reaches back 3 generations to 1997.

Decided
Jun 29, 2007
Review
431 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K963725 (1997). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor1999: 1 other ancestorK963725 · Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) · Card Guard, Ltd. · 1997K012012 · Ecg Home · H&C Medical Devices Spa · 2002K042814 · Readmyheart · Dailycare Biomedical, Inc. · 20051996199820002002200420062008
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor K042814 · Readmyheart · Dailycare Biomedical, Inc. · 2005K012012 · Ecg Home · H&C Medical Devices Spa · 2002K963725 · Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) · Card Guard, Ltd. · 19970
  1. Root · 3 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
  2. 2 generations backK012012 Ecg HomeH&C Medical Devices Spa · 2002
  3. 1 generation backK042814 ReadmyheartDailycare Biomedical, Inc. · 2005
  4. This deviceK061123 Palm Ecg Recorder, Model EP-201/202Parama-Tech Company., Ltd. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K963725Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified)Card Guard, Ltd.1997—
−2K012012Ecg HomeH&C Medical Devices Spa2002—
−1K042814ReadmyheartDailycare Biomedical, Inc.2005—
0 (this device)K061123Palm Ecg Recorder, Model EP-201/202Parama-Tech Company., Ltd.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200610
FIG. 1 — Lineage of K061123, 1997–2007Source: 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? (2)

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
*K042814Readmyheart
Summary page 1
…iograph Device Classification Class LI Common Name ECG monitor Predicate Device 1) Read My Heart K 042814, handlield ECG device 2) OMRON portable ECG Monitor, HCG-801…
Dailycare Biomedical, Inc.2005—
*K060766Portable, Electrocardiograph (Ecg) Monitor, Model HCG-801
Cleared while this submission was under review
Summary page 1
…1) Read My Heart K 042814, handlield ECG device 2) OMRON portable ECG Monitor, HCG-801 (K060766) Device Description The Palm ECG Recorder tnModel EP-20C1C202C, is made by Parama-Tech Co., Ltd. This wireless ECG Monitor is po…
Omron Healthcare, Inc.2006—

Also cleared against K042814: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 10 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
  • None of the 5 ancestors has a recall.
  • 4 other devices also cite its predicate K042814.

How does its category compare?

All DPS devices

DPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

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 Palm ECG Recordertm Model EP-201C/202C is intended for self-testing and home health care use. The Palm ECG Recordertm Model EP-201C/202C records, stores and transfers ECG waveforms, R-R graph and average heart rate data and presents these cardiological events in a synchronized time scale for interpretation by a physician trained in such an analysis. This is a prescription device for use only under the direction of a physician. A software user…

Read the full statement (121 words)

The Palm ECG Recordertm Model EP-201C/202C is intended for self-testing and home health care use. The Palm ECG Recordertm Model EP-201C/202C records, stores and transfers ECG waveforms, R-R graph and average heart rate data and presents these cardiological events in a synchronized time scale for interpretation by a physician trained in such an analysis. This is a prescription device for use only under the direction of a physician. A software user interface allows viewing. This screening tool is not intended for use as a diagnostic tool or as a substitute for a hospital diagnostic ECG device. This device is not intended for simultaneously recording and transmission of a user's ECG signal. This device is not recommended for use with implanted pacemakers.

Indications for use as stated in the FDA summary.

Also cleared against K042814

4 other devices cite the same predicate.

  • K162665MiCor A100 Wearable ECG RecorderMitac International Corp. · 2018
  • K062894Instantcheck RTD-Ecg Monitor, Model RMH4.0Dailycare Biomedical, Inc. · 2007
  • K052303Readmyheart, Model RMH2.0Dailycare Biomedical, Inc. · 2005
  • K050620Readmyheart, Model RMH3.0Dailycare Biomedical, Inc. · 2005

Recent decisions in DPS

The DPS category page

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  • K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc. · 2026

https://510kreport.com/device/K061123 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061123: Palm Ecg Recorder, Model EP-201/202.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061123

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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