510(k) · Cleared
ClearedHandheld Ecg Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Choice Electronic Technololgy Co., Ltd. · DPS Electrocardiograph
Cleared on Jul 19, 2012 as substantially equivalent to K052303 (Dailycare Biomedical, Inc., 2005) after a 315-day review. Its family tree reaches back 4 generations to 1997. 1 later device descends from it.
- Decided
- Jul 19, 2012
- Review
- 315 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K963725 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 3 generations backK012012 Ecg HomeH&C Medical Devices Spa · 2002
- 2 generations backK042814 ReadmyheartDailycare Biomedical, Inc. · 2005
- 1 generation backK052303 Readmyheart, Model RMH2.0Dailycare Biomedical, Inc. · 2005
- This deviceK112622 Handheld Ecg MonitorBeijing Choice Electronic Technololgy Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK152863 Portable ECG MonitorContec Medical Systems Co.,Ltd · 2016
Most influential descendants
Showing 1 of 1 · See all- K152863Portable ECG MonitorContec Medical Systems Co.,Ltd · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −3 | K012012 | Ecg Home | H&C Medical Devices Spa | 2002 | — |
| −2 | K042814 | Readmyheart | Dailycare Biomedical, Inc. | 2005 | — |
| −1 | K052303 | Readmyheart, Model RMH2.0 | Dailycare Biomedical, Inc. | 2005 | — |
| 0 (this device) | K112622 | Handheld Ecg Monitor | Beijing Choice Electronic Technololgy Co., Ltd. | 2012 | — |
| +1 | K152863 | Portable ECG Monitor | Contec Medical Systems Co.,Ltd | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
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 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052303 | Readmyheart, Model RMH2.0Summary page 2…to use this ' :version has simple user interface without EG rcliwngfnto.i 4 ~j5% Predicate Device Identification 510(k) Number: K052303 V. Product Name: ReadMyHeart Manufacturer: DailyCare BioMedical Inc. 6. Device Descrip… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152863 | Portable ECG Monitor | 2016 | 0 |
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 15 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K152863 (Contec Medical Systems Co.,Ltd, 2016) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K052303.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
The Handheld ECG Monitor OTC version is intended to record and store Lead I ECG signals, and display three ECG parameters for home health care use. The intended users are adults above 20 years old. This device is not intended to substitute for a hospital diagnostic ECG device. Users with implanted pacemaker are not recommended to use this device. The Handheld ECG Monitor OTC version has simple user interface without ECG trace viewing function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112622 · printed Nov 4, 2026
Cite this page
510(k) Report. “K112622: Handheld Ecg Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K112622
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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