510(k) · Cleared
ClearedHeartrak Smart at/Heartrak SMART2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Universal Medical, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Feb 5, 2004 as substantially equivalent to K960499 (Universal Medical, Inc., 1996) after a 98-day review. Its family tree reaches back 1 generation to 1996. 63 later devices descend from it.
- Decided
- Feb 5, 2004
- Review
- 98 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960499 (1996). 63 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK960499 Heartrak XLUniversal Medical, Inc. · 1996
- This deviceK033451 Heartrak Smart at/Heartrak SMART2Universal Medical, Inc. · 2004
- Descendant · cites it directly · 61 of its ownK071130 Heartrak AFUniversal Medical, Inc. · 2008
- Descendant · 2 generations on · 38 of its ownK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- Descendant · 3 generations on · 30 of its ownK111917 Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011
- Descendant · 4 generations on · 24 of its ownK113372 Nuvant, Mobilc Cardiac TelemetryCorventis, Inc. · 2012
- Descendant · 5 generations on · 23 of its ownK133701 Nuvant MCT SystemCorventis, Inc. · 2014
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K071130Heartrak AFUniversal Medical, Inc. · 2008 · cites it directly61descendants
- K091971Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) SystemCorventis, Inc. · 2009 · 2 generations on38descendants
- K111917Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011 · 3 generations on30descendants
- K113372Nuvant, Mobilc Cardiac TelemetryCorventis, Inc. · 2012 · 4 generations on24descendants
- K133701Nuvant MCT SystemCorventis, Inc. · 2014 · 5 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960499 | Heartrak XL | Universal Medical, Inc. | 1996 | — |
| 0 (this device) | K033451 | Heartrak Smart at/Heartrak SMART2 | Universal Medical, Inc. | 2004 | — |
| +1 | K071130 | Heartrak AF | Universal Medical, Inc. | 2008 | — |
| +2 | K091971 | Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT)… | Corventis, Inc. | 2009 | — |
| +3 | K111917 | Nuvant, Mobile Cardiac Telemetry | Corventis, Inc. | 2011 | — |
| +4 | K113372 | Nuvant, Mobilc Cardiac Telemetry | Corventis, Inc. | 2012 | — |
| +5 | K133701 | Nuvant MCT System | Corventis, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 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? (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 |
|---|---|---|---|
| * | K960499 | Heartrak XLSummary page 2…. Promotional Material: Promotional literature and advertisements for the device have not yet been prepared. Predicate Device: Heartrak XL (K960499) Substantial Equivalences: 2 The Heartrak Smart At/Heartrak Smart is substantially equiva… | 1996 |
What descends from it? (63)
See all 632 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?
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.
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?
Used as a supplement to Holter Monitoring to document infrequent/transient symptoms such as lightheadedness, chest discomfort, palpitations, pre-syncope and syncope events.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033451 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033451: Heartrak Smart at/Heartrak SMART2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033451
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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