510(k) · Cleared
ClearedStealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiac Insight, Inc. · DSH Recorder, Magnetic Tape, Medical
Cleared on Jul 11, 2015 as substantially equivalent to K042782 (Ge Medical Systems Information Technologies, 2005) and 2 other predicates after a 311-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Jul 11, 2015
- Review
- 311 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K963725 (1997). 18 ancestors in all, the oldest K882818 (1989). No later device cites it as a predicate yet.
- Root · 6 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 5 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 4 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 3 generations backK122184 Ecg CheckCardiac Designs, LLC · 2013
- 2 generations backK140933 Alivecor Heart MonitorAliveCor, Inc. · 2014 · Recalled
- 1 generation backK142743 AliveCor Heart MonitorAliveCor, Inc. · 2015
- This deviceK142468 Stealth Monitor, Stealth Docking Cable, Stealth DSD Software…Cardiac Insight, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −5 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −4 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −3 | K122184 | Ecg Check | Cardiac Designs, LLC | 2013 | — |
| −2 | K140933 | Alivecor Heart Monitor | AliveCor, Inc. | 2014 | 1 |
| −1 | K142743 | AliveCor Heart Monitor | AliveCor, Inc. | 2015 | — |
| 0 (this device) | K142468 | Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation… | Cardiac Insight, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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? (3)
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 |
|---|---|---|---|
| * | K042782 | Seer MCSummary page 4…870.2800 2. Predicate Device Identification Device Name Clearance Number Product Code SEER MC K042782 MLO AliveCor Heart Monitor K142743 DXH, DPS Stealth™ System (M100… | 2005 |
| * | K142743 | AliveCor Heart Monitor Cleared while this submission was under review Summary page 4…Clearance Number Product Code SEER MC K042782 MLO AliveCor Heart Monitor K142743 DXH, DPS Stealth™ System (M100) K130288 DSH All predicates are Cl… | 2015 |
| * | K130288 | Stealth Monitor, Stealth Docking Cable, Stealth Display and Storage DeviceSummary page 4…K042782 MLO AliveCor Heart Monitor K142743 DXH, DPS Stealth™ System (M100) K130288 DSH All predicates are Class II devices. 3. Indications for Use and Device Description Indications… | 2013 |
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 18 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 18 ancestors has a recall of any class.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Stealth™ Monitor is a prescription only single use, continuous recording ECG monitor that can be worn up to 168 hours (7 days) during activities of daily living. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, dizziness, anxiety, fatigue, syncope, pre-syncope, light-headedness, shortness of breath and where a software-assisted analysis of the potential causes of these symptoms is desirable.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142468 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142468: Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142468
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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