510(k) · Cleared
ClearedMaster Caution Device MCD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthwatch, Ltd. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Feb 17, 2015 as substantially equivalent to K113514 (Shl Telemedicine International, Ltd., 2012) and 3 other predicates after a 167-day review. Its family tree reaches back 6 generations to 1988. 6 later devices descend from it.
- Decided
- Feb 17, 2015
- Review
- 167 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K882803 (1988). 34 ancestors in all, the oldest K854030 (1986). 6 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 5 generations backK012241 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2002
- 4 generations backK052240 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc. · 2005
- 3 generations backK063222 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2006
- 2 generations backK072558 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2007
- 1 generation backK083287 Avivo Mobile Patient Management SystemCorventis, Inc. · 2009
- This deviceK142476 Master Caution Device MCDHealthwatch, Ltd. · 2015
- Descendant · cites it directly · 5 of its ownK161431 SimplECGNanowear, Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK201669 SimpleSENSENanowear, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK212160 SimpleSENSE PlatformNanowear, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK243981 Hexoskin Medical System (7100-00016)Carre Technologies, Inc. · 2025
- Descendant · 4 generations on · 0 of its ownK232053 SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K161431SimplECGNanowear, Inc. · 2016 · cites it directly5descendants
- K201669SimpleSENSENanowear, Inc. · 2020 · 2 generations on3descendants
- K212160SimpleSENSE PlatformNanowear, Inc. · 2021 · 3 generations on1descendant
- K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc. · 2025 · 3 generations on0descendants
- K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K882803 | ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST | Advanced Cardiovascular Systems, Inc. | 1988 | — |
| −5 | K012241 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001 | Cardionet, Inc. | 2002 | — |
| −4 | K052240 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002 | Cardionet, Inc. | 2005 | — |
| −3 | K063222 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004 | Cardionet, Inc. | 2006 | — |
| −2 | K072558 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 | Cardionet, Inc. | 2007 | — |
| −1 | K083287 | Avivo Mobile Patient Management System | Corventis, Inc. | 2009 | — |
| 0 (this device) | K142476 | Master Caution Device MCD | Healthwatch, Ltd. | 2015 | — |
| +1 | K161431 | SimplECG | Nanowear, Inc. | 2016 | — |
| +2 | K201669 | SimpleSENSE | Nanowear, Inc. | 2020 | — |
| +3 | K212160 | SimpleSENSE Platform | Nanowear, Inc. | 2021 | — |
| +3 | K243981 | Hexoskin Medical System (7100-00016) | Carre Technologies, Inc. | 2025 | — |
| +4 | K232053 | SimpleSense-BP, SimpleSense-BP Software Application | Nanowear, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 DXH? 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 DXH device
- #1 K243438 MEMO Patch M (MPT-E08R-UNC01)score 12.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K113514 | SmartheartSummary page 5…o the following predicate devices is claimed: Device Name 510k No Date of Clearance SHL Smartheart K113514 February 22, 2012 MotionWatch and Pro-Diary K132764 January 21, 2014… | 2012 |
| * | K132764 | Motion Watch and Pro-DiarySummary page 5…Clearance SHL Smartheart K113514 February 22, 2012 MotionWatch and Pro-Diary K132764 January 21, 2014 Avivo Mobile Patient K083287 February 3, 2009… | 2014 |
| * | K083287 | Avivo Mobile Patient Management SystemSummary page 5…h and Pro-Diary K132764 January 21, 2014 Avivo Mobile Patient K083287 February 3, 2009 Management System Hospira vital Signs wireless… | 2009 |
| * | K090610 | Hospira Vital Signs Wireless Monitoring SystemSummary page 5…K083287 February 3, 2009 Management System Hospira vital Signs wireless K090610 December 22, 2009 monitoring system Substantial Equivalence to Predicate Device The HealthWatc… | 2009 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 27 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 4 of the 34 ancestors have a recall of any class.
- Of its descendants, K161431 (Nanowear, Inc., 2016) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K113514.
How does its category compare?
All DXH devicesDXH Transmitters And Receivers, Electrocardiograph, Telephone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DXH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXH
322in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXH
27in 2025
MAUDE reports naming product code DXH, 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 | 3 | 202 | 0 | 0 |
| 2008 | 7 | 41 | 4 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 0 | — | 3 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 3 | 206 | 0 | 1 |
| 2014 | 6 | 186 | 0 | 1 |
| 2015 | 4 | 142 | 1 | 0 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 5 | 150 | 0 | 4 |
| 2018 | 4 | 294 | 0 | 0 |
| 2019 | 6 | 177 | 0 | 0 |
| 2020 | 5 | 141 | 0 | 5 |
| 2021 | 3 | 107 | 0 | 2 |
| 2022 | 4 | 150 | 0 | 6 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 4 | 322 | 0 | 27 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Master Caution Device (MCD) is intended to condition an electrocardiographic signal, so that it can be transmitted digitally via Bluetooth technology and cell-phone or communication device to a remote location. The Master Caution Device (MCD) is designed to be used by a patient to transmit a 12 lead ECG, posture and motion , respiration and skin temperature (IR) signals, in near real-time to enable review at a physician's office, hospital or other remote medical receiving center. Master Caution Device (MCD) target population is adults above the age of 21.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142476: Master Caution Device MCD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142476
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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