510(k) · Cleared
ClearedSpacelabs Medical Multi-Disclosure Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs Medical, Inc. · DXJ Display, Cathode-Ray Tube, Medical
Cleared on Jun 24, 1997 as substantially equivalent to K905788 (Hewlett-Packard Co., 1991) and 1 other predicate after a 341-day review. Its family tree reaches back 1 generation to 1984. 11 later devices descend from it.
- Decided
- Jun 24, 1997
- Review
- 341 days
- Class
- Class II
- Product code
- DXJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K840932 (1984). 2 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK840932 Muse-DPMarquette Electronics, Inc. · 1984
- This deviceK962811 Spacelabs Medical Multi-Disclosure WorkstationSpacelabs Medical, Inc. · 1997
- Descendant · cites it directly · 10 of its ownK073372 Electrophysiology Systems Integrator (Epsi)Systemsone · 2007
- Descendant · 2 generations on · 9 of its ownK083321 Cardio-ViewCurlview Igt, LLC · 2008
- Descendant · 3 generations on · 3 of its ownK111320 GlobalcardioCardiocomm Solutions, Inc. · 2011
- Descendant · 4 generations on · 2 of its ownK122632 Guava IICardiocomm Solutions, Inc. · 2014
- Descendant · 3 generations on · 2 of its ownK112645 Radiforce Large Monitor SystemEizo GmbH · 2011
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K073372Electrophysiology Systems Integrator (Epsi)Systemsone · 2007 · cites it directly10descendants
- K083321Cardio-ViewCurlview Igt, LLC · 2008 · 2 generations on9descendants
- K111320GlobalcardioCardiocomm Solutions, Inc. · 2011 · 3 generations on3descendants
- K122632Guava IICardiocomm Solutions, Inc. · 2014 · 4 generations on2descendants
- K112645Radiforce Large Monitor SystemEizo GmbH · 2011 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K840932 | Muse-DP | Marquette Electronics, Inc. | 1984 | — |
| 0 (this device) | K962811 | Spacelabs Medical Multi-Disclosure Workstation | Spacelabs Medical, Inc. | 1997 | — |
| +1 | K073372 | Electrophysiology Systems Integrator (Epsi) | Systemsone | 2007 | — |
| +2 | K083321 | Cardio-View | Curlview Igt, LLC | 2008 | — |
| +3 | K111320 | Globalcardio | Cardiocomm Solutions, Inc. | 2011 | — |
| +4 | K122632 | Guava II | Cardiocomm Solutions, Inc. | 2014 | — |
| +3 | K112645 | Radiforce Large Monitor System | Eizo GmbH | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 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 |
|---|---|---|---|
| * | K905788 | Model M1251A Mon. Full Disclosure Review SystemSummary page 1…quivalent to workstations currently marketed by Hewlett-Packard Company and Marquette Electronics, Inc. Hewlett-Packard markets the M1251A Full Disclosure Review System (K905788) which collects waveform data and provides support for the review, editing, archival and printing of this data. The Marquette Mus… | 1991 |
| * | K840932 | Muse-DPSummary page 1…(K905788) which collects waveform data and provides support for the review, editing, archival and printing of this data. The Marquette Muse Cardiology Management System (K840932) includes these features for the on-line review of 12-lead ECG reports and their subsequent archival for later retrieval. The Sp… | 1984 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073372 | Electrophysiology Systems Integrator (Epsi) | 2007 | 10 |
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.
- Of its descendants, K073372 (Systemsone, 2007) has gone furthest, with 10 descendants of its own.
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?
Data Access - Provides the user with the means to collect multiple patient data directly from a hardwired or telemetry Patient Care Management System (PCMS) monitoring network. Data Storage - Allows the user to retain up to 48 patient waveforms for up to 48 hours. Data Display - Allows the user to pull data from storage or during continuous monitoring by patient and parameter. Data Editing - Provides the user with the means to edit 12-lead ECG waveform…
Read the full statement (118 words)
Data Access - Provides the user with the means to collect multiple patient data directly from a hardwired or telemetry Patient Care Management System (PCMS) monitoring network.
Data Storage - Allows the user to retain up to 48 patient waveforms for up to 48 hours.
Data Display - Allows the user to pull data from storage or during continuous monitoring by patient and parameter.
Data Editing - Provides the user with the means to edit 12-lead ECG waveform data and interpretation text from Spacelabs Medical 12-lead modules connected to the Patient Care Management System (PCMS) monitoring network.
Data Printing - Allows the user to print time annotated waveforms and patient data on paper for review or archive history.
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/K962811 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962811: Spacelabs Medical Multi-Disclosure Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962811
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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