510(k) · Cleared
ClearedModel M1251A Mon. Full Disclosure Review System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hewlett-Packard Co. · DXJ Display, Cathode-Ray Tube, Medical
Cleared on Jun 6, 1991 after a 161-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Jun 6, 1991
- Review
- 161 days
- Class
- Class II
- Product code
- DXJ
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK905788 Model M1251A Mon. Full Disclosure Review SystemHewlett-Packard Co. · 1991
- Descendant · cites it directly · 11 of its ownK962811 Spacelabs Medical Multi-Disclosure WorkstationSpacelabs Medical, Inc. · 1997
- Descendant · 2 generations on · 10 of its ownK073372 Electrophysiology Systems Integrator (Epsi)Systemsone · 2007
- Descendant · 3 generations on · 9 of its ownK083321 Cardio-ViewCurlview Igt, LLC · 2008
- Descendant · 4 generations on · 3 of its ownK111320 GlobalcardioCardiocomm Solutions, Inc. · 2011
- Descendant · 5 generations on · 2 of its ownK122632 Guava IICardiocomm Solutions, Inc. · 2014
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K962811Spacelabs Medical Multi-Disclosure WorkstationSpacelabs Medical, Inc. · 1997 · cites it directly11descendants
- K073372Electrophysiology Systems Integrator (Epsi)Systemsone · 2007 · 2 generations on10descendants
- K083321Cardio-ViewCurlview Igt, LLC · 2008 · 3 generations on9descendants
- K111320GlobalcardioCardiocomm Solutions, Inc. · 2011 · 4 generations on3descendants
- K122632Guava IICardiocomm Solutions, Inc. · 2014 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K905788 | Model M1251A Mon. Full Disclosure Review System | Hewlett-Packard Co. | 1991 | — |
| +1 | K962811 | Spacelabs Medical Multi-Disclosure Workstation | Spacelabs Medical, Inc. | 1997 | — |
| +2 | K073372 | Electrophysiology Systems Integrator (Epsi) | Systemsone | 2007 | — |
| +3 | K083321 | Cardio-View | Curlview Igt, LLC | 2008 | — |
| +4 | K111320 | Globalcardio | Cardiocomm Solutions, Inc. | 2011 | — |
| +5 | K122632 | Guava II | Cardiocomm Solutions, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962811 | Spacelabs Medical Multi-Disclosure Workstation | 1997 | 11 |
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?
- Of its descendants, K962811 (Spacelabs Medical, Inc., 1997) has gone furthest, with 11 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 | — |
https://510kreport.com/device/K905788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K905788: Model M1251A Mon. Full Disclosure Review System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905788
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026