510(k) · Cleared
ClearedHEART 1001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aerotel, Ltd. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Jan 11, 1995 after a 684-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jan 11, 1995
- Review
- 684 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK931020 HEART 1001Aerotel, Ltd. · 1995
- Descendant · cites it directly · 0 of its ownK023418 Heartone Event Recorder and TransmitterAerotel Medical Systems (1998), Ltd. · 2002
- Descendant · cites it directly · 0 of its ownK980144 Heartview P12/8 Electrocardiograph Recorder and TransmitterAerotel, Ltd. · 1998
- Descendant · cites it directly · 0 of its ownK953762 Heart 400 Ecg TransmitterAerotel, Ltd. · 1996
Most influential descendants
Showing 3 of 3 · See all- K023418Heartone Event Recorder and TransmitterAerotel Medical Systems (1998), Ltd. · 2002 · cites it directly0descendants
- K980144Heartview P12/8 Electrocardiograph Recorder and TransmitterAerotel, Ltd. · 1998 · cites it directly0descendants
- K953762Heart 400 Ecg TransmitterAerotel, Ltd. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K931020 | HEART 1001 | Aerotel, Ltd. | 1995 | — |
| +1 | K023418 | Heartone Event Recorder and Transmitter | Aerotel Medical Systems (1998), Ltd. | 2002 | — |
| +1 | K980144 | Heartview P12/8 Electrocardiograph Recorder and Transmitter | Aerotel, Ltd. | 1998 | — |
| +1 | K953762 | Heart 400 Ecg Transmitter | Aerotel, Ltd. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
3 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?
- Of its descendants, K023418 (Aerotel Medical Systems (1998), Ltd., 2002) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K931020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K931020: HEART 1001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931020
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026