510(k) · Cleared
Recalled · Class II · 2018Solar 9500 Information Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jan 15, 2004 as substantially equivalent to K030575 (Ge Medical Systems Information Technologies, 2003) after a 24-day review. Its family tree reaches back 4 generations to 1990. It has been recalled once.
- Decided
- Jan 15, 2004
- Review
- 24 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K900598 (1990). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK900598 Tramscope SystemMarquette Electronics, Inc. · 1990
- 3 generations backK954852 Solar 9000 Anesthesia Information MonitorMarquette Electronics, Inc. · 1996
- 2 generations backK990068 Solar 9500 Information MonitorGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- 1 generation backK030575 Modification to Solar 9500 Information MonitorGe Medical Systems Information Technologies · 2003 · Recalled
- This deviceK033964 Solar 9500 Information MonitorGe Medical Systems Information Technologies · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K900598 | Tramscope System | Marquette Electronics, Inc. | 1990 | — |
| −3 | K954852 | Solar 9000 Anesthesia Information Monitor | Marquette Electronics, Inc. | 1996 | — |
| −2 | K990068 | Solar 9500 Information Monitor | General Electric Medical Systems Information Techn | 1999 | 1 |
| −1 | K030575 | Modification to Solar 9500 Information Monitor | Ge Medical Systems Information Technologies | 2003 | 2 |
| 0 (this device) | K033964 | Solar 9500 Information Monitor | Ge Medical Systems Information Technologies | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
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 MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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 |
|---|---|---|---|
| * | K030575 | Modification to Solar 9500 Information MonitorSummary page 1…alarm) 74DRT 21 CFR 870.2700 Oximeter, Pulse 74DQA Predicate Device: K030575 Solar 9500 Information Monitor Device Description: The Solar 9500 is a patient monitoring system that is desig… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2018 | Class II | Z-0524-2019 | Software design | The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The Solar® 9500 Information Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients, in high acuity areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive…
Read the full statement (152 words)
The Solar® 9500 Information Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients, in high acuity areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. Physiologic data includes electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, oxygen, anesthetic gas concentrations and mixed venous oxygen saturation, as summarized in the Solar® 9500 Operator's Manual.
The Solar® 9500 Information Monitoring System is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital INTRAnet data via a Web Browser at the point-of-care.
This information can be displayed, trended, stored, and printed.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033964 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033964: Solar 9500 Information Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033964
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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