510(k) · Cleared
ClearedSolar 9000 Anesthesia Information Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marquette Electronics, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on May 29, 1996 as substantially equivalent to K900598 (Marquette Electronics, Inc., 1990) after a 219-day review. Its family tree reaches back 1 generation to 1990. 4 later devices descend from it.
- Decided
- May 29, 1996
- Review
- 219 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K900598 (1990). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK900598 Tramscope SystemMarquette Electronics, Inc. · 1990
- This deviceK954852 Solar 9000 Anesthesia Information MonitorMarquette Electronics, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK990068 Solar 9500 Information MonitorGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- Descendant · 2 generations on · 1 of its ownK030575 Modification to Solar 9500 Information MonitorGe Medical Systems Information Technologies · 2003 · Recalled
- Descendant · 3 generations on · 0 of its ownK033964 Solar 9500 Information MonitorGe Medical Systems Information Technologies · 2004 · Recalled
- Descendant · cites it directly · 0 of its ownK980756 Corometrics Transcutaneous TCPO2/CO2 ModuleGe Medical Systems Information Technologies · 1998
Most influential descendants
Showing 4 of 4 · See all- K990068Solar 9500 Information MonitorGeneral Electric Medical Systems Information Techn · 1999 · cites it directly2descendants
- K030575Modification to Solar 9500 Information MonitorGe Medical Systems Information Technologies · 2003 · 2 generations on1descendant
- K033964Solar 9500 Information MonitorGe Medical Systems Information Technologies · 2004 · 3 generations on0descendants
- K980756Corometrics Transcutaneous TCPO2/CO2 ModuleGe Medical Systems Information Technologies · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900598 | Tramscope System | Marquette Electronics, Inc. | 1990 | — |
| 0 (this device) | K954852 | Solar 9000 Anesthesia Information Monitor | Marquette Electronics, Inc. | 1996 | — |
| +1 | K990068 | Solar 9500 Information Monitor | General Electric Medical Systems Information Techn | 1999 | 1 |
| +2 | K030575 | Modification to Solar 9500 Information Monitor | Ge Medical Systems Information Technologies | 2003 | 2 |
| +3 | K033964 | Solar 9500 Information Monitor | Ge Medical Systems Information Technologies | 2004 | 1 |
| +1 | K980756 | Corometrics Transcutaneous TCPO2/CO2 Module | Ge Medical Systems Information Technologies | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 DSI? 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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 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 |
|---|---|---|---|
| * | K900598 | Tramscope System Our OCR of the scanned summary read K900588, FDA’s number for Acu-Band Accupressure Wrist Band (Euro-Am Pharma, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Tramscope System”. | 1990 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Use of the Marquette Solar 9000 Anesthesia Information Monitor is intended for patient popuhfiom including: adult, pediatric, and/ or neonatal. Use of the Marquetite Solar 9000 Anesthesia information Monitor is not recommended for use in patient’s home or residence, during patient transport, or when it has not been ordered by a physician or other quaiified personnel. Use of the Marquette Solar 9000 Anesthesia Information Monitor is intended for operating…
Read the full statement (139 words)
Use of the Marquette Solar 9000 Anesthesia Information Monitor is intended for patient popuhfiom including: adult, pediatric, and/ or neonatal.
Use of the Marquetite Solar 9000 Anesthesia information Monitor is not recommended for use in patient’s home or residence, during patient transport, or when it has not been ordered by a physician or other quaiified personnel.
Use of the Marquette Solar 9000 Anesthesia Information Monitor is intended for operating room (OR), post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive csre. These departments are typically located in hospitals or may be located in outpatient clinics or free standing surgical centers. It is intended for use by physicians, physician assistants, registered nurses, certified registered nurse anesthetists, or other hospital personnel trained in the use of the equipment.
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/K954852 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954852: Solar 9000 Anesthesia Information Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954852
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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