510(k) · Cleared
ClearedCardiophonics 1000 Memory Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rlt Medical Assoc., Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Sep 17, 1999 as substantially equivalent to K934975 (Rlt Medical Assoc., Inc., 1995) after a 30-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Sep 17, 1999
- Review
- 30 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934975 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK934975 Telephone Electrocardiograph TransmitterRlt Medical Assoc., Inc. · 1995
- This deviceK992772 Cardiophonics 1000 Memory MonitorRlt Medical Assoc., Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934975 | Telephone Electrocardiograph Transmitter | Rlt Medical Assoc., Inc. | 1995 | — |
| 0 (this device) | K992772 | Cardiophonics 1000 Memory Monitor | Rlt Medical Assoc., Inc. | 1999 | — |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 |
|---|---|---|---|
| * | K934975 | Telephone Electrocardiograph TransmitterSummary page 3…am. All data is then reviewed by a health professional. This is the same intended use and purpose as previously cleared for the Cardiophonics Memory Transmitter. { 510K K934975 } ik (Divist nfiigfl'om Division of Ca and Neurological Devicss , ¢, 7\ 72 510(k) NUMDOr e G699 w | 1995 |
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.
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 Cardiophonics memory transmitter is a two-channel cardiac event recorder. It incorporates a microprocessor and analog to digital conversion circuits. This allows the unit to store ECG data in a memory loop configuration. This ECG data is then sent over a analog phone line or RS-232 serial port for display by a PC receiving station. The monitor may be configured and programmed either by the program keys on the monitor or by the PC Cardiophonics 1000 software program. All data is then reviewed by a health professional.
This is the same intended use and purpose as previously cleared for the Cardiophonics Memory Transmitter. { 510K K934975 }
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992772 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992772: Cardiophonics 1000 Memory Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992772
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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