510(k) · Cleared
ClearedRetrospective II-Elite Ecg Memory Loop Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiac Evaluation Center, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Jul 11, 1996 as substantially equivalent to K831406 (Cardiac Evaluation Center, Inc., 1983) after a 310-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Jul 11, 1996
- Review
- 310 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K831406 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backK831406 Restrospective Ecg Memory ModuleCardiac Evaluation Center, Inc. · 1983
- This deviceK954163 Retrospective II-Elite Ecg Memory Loop RecorderCardiac Evaluation Center, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831406 | Restrospective Ecg Memory Module | Cardiac Evaluation Center, Inc. | 1983 | — |
| 0 (this device) | K954163 | Retrospective II-Elite Ecg Memory Loop Recorder | Cardiac Evaluation Center, Inc. | 1996 | — |
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 |
|---|---|---|---|
| * | K831406 | Restrospective Ecg Memory ModuleSummary page 1…ographic, Telephone. Classification Number: 74DXH Claimed Predicate Device: Retrospective ECG Memory Loop Recorder Manufacturer: CEC Medical Systems 510(K) Document #: K831406 Description of Device The Retrospective |l is a portable ECG memory lcop recorder. It is a non-critical Type Il device. The dev… | 1983 |
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 sole intended use for the device or its predicate is for the long term monitoring of ECG in occasionally symptomatic patients. The purpose of both devices is to record occasional short-lived arrhythmia. Their usage is usually confined to otherwise healthy individuals on an out-patient basis. These recorders are not meant for use in life support or ICU situations. Their normal function is to record all ECG data and save a particular episode only when…
Read the full statement (142 words)
The sole intended use for the device or its predicate is for the long term monitoring of ECG in occasionally symptomatic patients. The purpose of both devices is to record occasional short-lived arrhythmia. Their usage is usually confined to otherwise healthy individuals on an out-patient basis. These recorders are not meant for use in life support or ICU situations. Their normal function is to record all ECG data and save a particular episode only when activated by the patient. The stored episode contains data before and after the activation so that the actual arrhythmia will be captured. The data is then saved for transmission to a qualified technician for interpretation. The recorders take no action and advises none to the patient other than to call the receiving station. They are totally passive devices and offers no diagnosis or perform any signal analysis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K954163 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954163: Retrospective II-Elite Ecg Memory Loop Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954163
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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