510(k) · Cleared
ClearedHeartline Receiving Station
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aerotel Medical Systems (1998), Ltd. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Jul 24, 2002 as substantially equivalent to K930314 (Aerotel, Ltd., 1994) after a 28-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jul 24, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930314 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK930314 Heartline Transtelephonic Ecg Receiving ConsoleAerotel, Ltd. · 1994
- This deviceK022073 Heartline Receiving StationAerotel Medical Systems (1998), Ltd. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930314 | Heartline Transtelephonic Ecg Receiving Console | Aerotel, Ltd. | 1994 | — |
| 0 (this device) | K022073 | Heartline Receiving Station | Aerotel Medical Systems (1998), Ltd. | 2002 | — |
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 |
|---|---|---|---|
| * | K930314 | Heartline Transtelephonic Ecg Receiving ConsoleSummary page 1…ation name: Transmitters and Receivers, Electrocardiograph,Telephone 74 KGJ. (3) Equivalent legally-marketeddevices. Aerotel Heartline receiving Console, K9303 14 (4) Description The Heartline is an ECG monitoring device intended to receive ECG signals Aerotel Heartl… | 1994 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K930314.
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?
The Heartline is an ECG monitoring device intended to receive ECG signals over standard telephone lines from patient operated transmitters when decoded, received signals are recorded and patient data can be displayed on a PC monitor for physicians analysis and comment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022073 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022073: Heartline Receiving Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022073
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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