510(k) · Cleared
ClearedEcg Review Station
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mortara Instrument, Inc. · DXJ Display, Cathode-Ray Tube, Medical
Cleared on Aug 12, 1997 as substantially equivalent to K895232 (Mortara Instrument, Inc., 1989) and 1 other predicate after a 1,162-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Aug 12, 1997
- Review
- 1,162 days
- Class
- Class II
- Product code
- DXJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K895232 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK895232 Model Eli-100/ST ElectrocardiographMortara Instrument, Inc. · 1989
- This deviceK942685 Ecg Review StationMortara Instrument, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895232 | Model Eli-100/ST Electrocardiograph | Mortara Instrument, Inc. | 1989 | — |
| 0 (this device) | K942685 | Ecg Review Station | Mortara Instrument, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 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 DXJ? 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 DXJ device
- #1 K261469 Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0…score 12.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K895232 | Model Eli-100/ST ElectrocardiographSummary page 1…eveloped software that provides for the means to graphically view and/or present the ECG data captured and stored by the ELI 100/STM (legally marketed predicate device — K895232), including ST scgment measurenenly, Intended Use: The ST Review Station is intended to allow Physicians and/or Clinical person… | 1989 |
| * | K922927 | Mortara Instrument ST Central StationSummary page 2…544760 ST Review Station 510(k) Summary Attachment 1 Tabular Comparison of Predicate Device's Featurcs ELI 100/STM ST Central Station | ST Review Station (K895232) (K922927) (K942683) Predicate Device Predicate Device Premarket Notification Computer Based Na - 12-lead FKG that | Yes -- Central displ… | 1992 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All DXJ devicesDXJ Display, Cathode-Ray Tube, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXJ
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · DXJ
130in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXJ
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXJ
3in 2025
MAUDE reports naming product code DXJ, 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 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 2 | 5 |
| 2009 | 0 | — | 8 | 29 |
| 2010 | 2 | — | 1 | 148 |
| 2011 | 4 | 53 | 1 | 129 |
| 2012 | 1 | — | 0 | 21 |
| 2013 | 3 | 174 | 0 | 4 |
| 2014 | 4 | 242 | 0 | 13 |
| 2015 | 2 | — | 0 | 15 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 4 | 164 | 0 | 10 |
| 2018 | 4 | 130 | 0 | 3 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 1 | — | 0 | 22 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 0 | — | 1 | 2 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 2 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ST Review Station is intended to allow Physicians and/or Clinical personnel from ER. Cath Lab, ICU, and other related settings to retiospectively review/analyze stored ECG data. By bcing able review/analyze ECG trends, including ST segment measurements, Clinicians and/or Physicians have access to information 10 assist in their ability to detect changes in a paticnts physiological condition and therefore enabling them to respond accordingly to a paticnts medical needs.
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/K942685 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942685: Ecg Review Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942685
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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