510(k) · Cleared
ClearedAT-Patch (ATP-C130/ATP-C70)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atsens Co., Ltd. · DSH Recorder, Magnetic Tape, Medical
Cleared on May 2, 2025 as substantially equivalent to K203638 (Atsens Co., Ltd., 2022) and 1 other predicate after a 245-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- May 2, 2025
- Review
- 245 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K930806 (1994). 43 ancestors in all, the oldest K881905 (1988). No later device cites it as a predicate yet.
- Root · 8 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 7 generations backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- 6 generations backK990170 Holter 2000Zymed Medical Instrumentation · 1999
- 5 generations backK010949 2010 Plus Holter for WindowsAgilent Technologies · 2001
- 4 generations backK051026 Mars Holter Analysis WorkstationGe Medical Systems Information Technologies · 2005
- 3 generations backK093141 Mars Holter Analysis WorkstationGe Medical Systems Information Technologies · 2009
- 2 generations backK132437 Mars Holter Analysis WorkstationGe Medical Systems Information Technologies, Inc. · 2013
- 1 generation backK162023 CardioDay V2.5Getemed Medizin- Und Informationstechnik AG · 2017
- This deviceK242583 AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −7 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| −6 | K990170 | Holter 2000 | Zymed Medical Instrumentation | 1999 | — |
| −5 | K010949 | 2010 Plus Holter for Windows | Agilent Technologies | 2001 | — |
| −4 | K051026 | Mars Holter Analysis Workstation | Ge Medical Systems Information Technologies | 2005 | — |
| −3 | K093141 | Mars Holter Analysis Workstation | Ge Medical Systems Information Technologies | 2009 | — |
| −2 | K132437 | Mars Holter Analysis Workstation | Ge Medical Systems Information Technologies, Inc. | 2013 | — |
| −1 | K162023 | CardioDay V2.5 | Getemed Medizin- Und Informationstechnik AG | 2017 | — |
| 0 (this device) | K242583 | AT-Patch (ATP-C130/ATP-C70) | Atsens Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 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 DSH? 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 DSH device
- #1 K260157 LifeLens Physiological Monitorscore 17.9 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K203638 | AT-Patch ECG Analysis SystemSummary page 5…21CFR870.1425 Device Class 2 Product Code DSH, DQK, MLO 4. Predicate Device Information 4.1 Predicate device 1 (K203638) Manufacturer ATsens Co., Ltd. Device Name AT-Patch ECG Analysis System 510(k)… | 2022 |
| * | K162023 | CardioDay V2.5Summary page 6…K203638 Page 1 / 15 K242583 4.2 Predicate device 2 (K162023) Manufacturer GETEMED Medizin-und informationstechnik AG Device Name CardioDay V2.… | 2017 |
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 31 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- None of the 43 ancestors has a recall.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DSH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSH
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSH
No recall names DSH since 2007.
Adverse event reports per year · DSH
213in 2025
MAUDE reports naming product code DSH, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 84 | 0 | 1 |
| 2010 | 2 | — | 0 | 8 |
| 2011 | 6 | 64 | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 3 | 91 | 0 | 31 |
| 2018 | 3 | 269 | 0 | 30 |
| 2019 | 3 | 30 | 0 | 76 |
| 2020 | 4 | 122 | 0 | 91 |
| 2021 | 4 | 263 | 0 | 113 |
| 2022 | 4 | 427 | 0 | 46 |
| 2023 | 6 | 198 | 0 | 65 |
| 2024 | 2 | — | 0 | 88 |
| 2025 | 4 | 205 | 0 | 213 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The device is intended to measure, analyze, edit and report continuous electrocardiogram (ECG) information for long-term recording (ATP-C130: up to 14 days, ATP-C70: up to 7 days) by attaching to the patient’s torso. ECG records are saved in the device during use and are not intended for real-time monitoring. After the wear period is completed, the ECG data is transmitted to the AT-Report. A primary analysis is performed by the algorithms within the…
Read the full statement (166 words)
The device is intended to measure, analyze, edit and report continuous electrocardiogram (ECG) information for long-term recording (ATP-C130: up to 14 days, ATP-C70: up to 7 days) by attaching to the patient’s torso. ECG records are saved in the device during use and are not intended for real-time monitoring. After the wear period is completed, the ECG data is transmitted to the AT-Report. A primary analysis is performed by the algorithms within the AT-Report, and then a physician report is issued based on those results after a secondary analysis by a clinician or trained operator with experience in ECG analysis to correct any incorrectly detected events. The Physician report is offered to clinicians or physicians on an advisory basis only. The device is used by patients as prescribed by physicians or medical personnel. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, fatigue, or anxiety.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242583: AT-Patch (ATP-C130/ATP-C70).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242583
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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