510(k) · Cleared
ClearedSOLAR 7/8000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Medical Systems Information Techn · DSI Detector And Alarm, Arrhythmia
Cleared on Mar 23, 2000 as substantially equivalent to K900598 (Marquette Electronics, Inc., 1990) and 1 other predicate after a 139-day review. Its family tree reaches back 1 generation to 1990. 5 of the 119 devices in its family, counting itself, have a Class I recall. 116 later devices descend from it.
- Decided
- Mar 23, 2000
- Review
- 139 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K900598 (1990). 2 ancestors in all. 116 later devices descend from it, 2 citing it directly. 5 of the 119 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK900598 Tramscope SystemMarquette Electronics, Inc. · 1990
- This deviceK993757 SOLAR 7/8000General Electric Medical Systems Information Techn · 2000
- Descendant · cites it directly · 100 of its ownK012467 Solar 8000M SystemGeneral Electric Medical Systems Information Techn · 2002 · Recalled
- Descendant · 2 generations on · 51 of its ownK071073 Solar 8000 and Transport Pro with Patient Data ModuleGe Medical Systems Information Technologies · 2007 · Recalled
- Descendant · 2 generations on · 47 of its ownK070791 PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- Descendant · 3 generations on · 38 of its ownK092027 Carescape Monitor B850Ge Medical Systems Information Technologies · 2009 · Recalled
- Descendant · 4 generations on · 32 of its ownK102239 Carescape Monitor B650GE Healthcare Finland Oy · 2010 · Recalled
Showing 5 of 116 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 116 · See all- K012467Solar 8000M SystemGeneral Electric Medical Systems Information Techn · 2002 · cites it directly100descendants
- K071073Solar 8000 and Transport Pro with Patient Data ModuleGe Medical Systems Information Technologies · 2007 · 2 generations on51descendants
- K070791PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · 2 generations on47descendants
- K092027Carescape Monitor B850Ge Medical Systems Information Technologies · 2009 · 3 generations on38descendants
- K102239Carescape Monitor B650GE Healthcare Finland Oy · 2010 · 4 generations on32descendants
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) | K993757 | SOLAR 7/8000 | General Electric Medical Systems Information Techn | 2000 | — |
| +1 | K012467 | Solar 8000M System | General Electric Medical Systems Information Techn | 2002 | 2 |
| +2 | K071073 | Solar 8000 and Transport Pro with Patient Data Module | Ge Medical Systems Information Technologies | 2007 | 13 |
| +2 | K070791 | PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| +3 | K092027 | Carescape Monitor B850 | Ge Medical Systems Information Technologies | 2009 | 9 |
| +4 | K102239 | Carescape Monitor B650 | GE Healthcare Finland Oy | 2010 | 8 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 5 | 1 |
| 2007 | 3 | 0 |
| 2008 | 4 | 1 |
| 2009 | 7 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 7 | 2 |
| 2015 | 7 | 0 |
| 2016 | 6 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2022 | 10 | 0 |
| 2023 | 8 | 1 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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.
5 devices in this family have a Class I recall. 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? (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 |
|---|---|---|---|
| * | K900598 | Tramscope SystemSummary page 1…ac Output, Thermal (Balloon Type Catheter) Monitor, Temperature (with probe) Monitor, Cardiac (Incl. cardiotachometer & rate alarm) Oximeter, Pulse Predicate Devices: K900598 Marquette Tramscope System K921669 Marquette SL Series Transport Remote Acquisition Module MAR 23 . Device Descr… | 1990 |
| * | K921669 | Marquette SL Series Transport Remote AcquisitionSummary page 1…theter) Monitor, Temperature (with probe) Monitor, Cardiac (Incl. cardiotachometer & rate alarm) Oximeter, Pulse Predicate Devices: K900598 Marquette Tramscope System K921669 Marquette SL Series Transport Remote Acquisition Module MAR 23 . Device Description: Intended Use: Technology:… | 1993 |
What descends from it? (116)
See all 1162 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K133886Perseus A500Draeger Medical GmbH · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K042419Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004 · 4 generations on · ◆ in the 2004 descendants bar of FIG. 14 Class I recalls
- K230931AtlanDrägerwerk AG Co. Kgaa · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 18 Class I recalls
- K072884Fabius MriDraeger Medical AG & Co. KG · 2008 · 5 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 6 generations on · ◆ in the 2014 descendants bar of FIG. 11 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?
The Solar 7/8000 System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The intended use of the system is to monitor physiologic parameter data on adult, pedlatnc and neonatal patients within a hospital or facility providing patient care. Physiologic parameter data includes: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac…
Read the full statement (152 words)
The Solar 7/8000 System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The intended use of the system is to monitor physiologic parameter data on adult, pedlatnc and neonatal patients within a hospital or facility providing patient care.
Physiologic parameter data includes: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, end tidal CO,, pulse oximetry, venous O, saturation, Transcutaneous O, and/or CO,, respiratory mechanics, and/or (for adult and/or pediatric patients) anesthetic agent concentrations. O, and/or CO, concentrations are available for neonates not under anesthesia. Information can be displayed, trended and stored in the monitor from a variety of peripheral devices.
The Solar 7/8000 System is also intended to provide physiologic data over the UNITY™ network.
The Solar 7/8000 System was developed to interface with third party peripheral devices that support serial and/or analog data outputs.
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/K993757 · printed Nov 3, 2026
Cite this page
510(k) Report. “K993757: SOLAR 7/8000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K993757
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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