510(k) · Cleared
Recalled · Class II · 2018Solar 8000M System
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 Feb 11, 2002 as substantially equivalent to K993757 (General Electric Medical Systems Information Techn, 2000) after a 194-day review. Its family tree reaches back 2 generations to 1990. 1 of the 104 devices in its family, counting itself, has a Class I recall. 100 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 11, 2002
- Review
- 194 days
- Class
- Class II
- Product code
- DSI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K900598 (1990). 3 ancestors in all. 100 later devices descend from it, 2 citing it directly. 1 of the 104 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK900598 Tramscope SystemMarquette Electronics, Inc. · 1990
- 1 generation backK993757 SOLAR 7/8000General Electric Medical Systems Information Techn · 2000
- This deviceK012467 Solar 8000M SystemGeneral Electric Medical Systems Information Techn · 2002
- Descendant · cites it directly · 51 of its ownK071073 Solar 8000 and Transport Pro with Patient Data ModuleGe Medical Systems Information Technologies · 2007 · Recalled
- Descendant · cites it directly · 47 of its ownK070791 PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- Descendant · 2 generations on · 38 of its ownK092027 Carescape Monitor B850Ge Medical Systems Information Technologies · 2009 · Recalled
- Descendant · 3 generations on · 32 of its ownK102239 Carescape Monitor B650GE Healthcare Finland Oy · 2010 · Recalled
- Descendant · 2 generations on · 19 of its ownK072581 PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
Showing 5 of 100 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K133576 Monitor B405 generations on · 2014
Most influential descendants
Showing 5 of 100 · See all- K071073Solar 8000 and Transport Pro with Patient Data ModuleGe Medical Systems Information Technologies · 2007 · cites it directly51descendants
- K070791PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · cites it directly47descendants
- K092027Carescape Monitor B850Ge Medical Systems Information Technologies · 2009 · 2 generations on38descendants
- K102239Carescape Monitor B650GE Healthcare Finland Oy · 2010 · 3 generations on32descendants
- K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 2 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900598 | Tramscope System | Marquette Electronics, Inc. | 1990 | — |
| −1 | K993757 | SOLAR 7/8000 | General Electric Medical Systems Information Techn | 2000 | — |
| 0 (this device) | K012467 | Solar 8000M System | General Electric Medical Systems Information Techn | 2002 | — |
| +1 | K071073 | Solar 8000 and Transport Pro with Patient Data Module | Ge Medical Systems Information Technologies | 2007 | 13 |
| +1 | K070791 | PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| +2 | K092027 | Carescape Monitor B850 | Ge Medical Systems Information Technologies | 2009 | 9 |
| +3 | K102239 | Carescape Monitor B650 | GE Healthcare Finland Oy | 2010 | 8 |
| +2 | K072581 | PM-60 Pulse Oximeter | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
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 |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 7 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 5 | 1 |
| 2015 | 5 | 0 |
| 2016 | 6 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 10 | 0 |
| 2023 | 7 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K993757 | SOLAR 7/8000Summary page 1…E Medical Systemns Information Technologies Phone: (414) 362-3329 Fax: (414) 918-8114 Solar 8000M System ‘ Physiological Patient Monitor Physiological Patient Monitor K993757 Solar 7/8000 System The Solar 8000M System includes the following basic components: Solar 8000M processing unit a display TRAM… | 2000 |
What descends from it? (100)
See all 1002 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2018 | Class II | Z-0523-2019 | 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. |
| Apr 2, 2008 | Not classified | Z-0285-2009 | Software design | A software error has been discovered when using Combination Monitoring with Solar 8000M/i - PDM - Telemetry in combo mode. This error has only been noted with this particular configuration and mode of monitoring. It has not been observed… |
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.
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 9.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K071073 (Ge Medical Systems Information Technologies, 2007) has gone furthest, with 51 descendants of its own.
- 1 other device also cites its predicate K993757.
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 8000M System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in the use of the equipment. The Solar 8000M is a multiparameter physiclogical patient monitoring system intended for use on adult, pediatric and necnatal patients, within a hospital or facility environment. The Solar 8000M System is capable of monitoring electrocardiogram, invasive blood pressure, non-invasive bleod…
Read the full statement (161 words)
The Solar 8000M System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in the use of the equipment. The Solar 8000M is a multiparameter physiclogical patient monitoring system intended for use on adult, pediatric and necnatal patients, within a hospital or facility environment.
The Solar 8000M System is capable of monitoring electrocardiogram, invasive blood pressure, non-invasive bleod pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, venous O, saturation, Transcutaneous O, and CO; respiratory mechanics, and/or (for aduit and/or pediatric patients) anesthetic agent concentrations, impedance cardiography, electroencephalography and bispectral index. O, and CO, concentrations are available for neonates not under anesthesia. Information can be displayed, trended and stared in the monitor from a variety of peripheral devices.
The Solar 8000M System is also intended to provide physiologic data over the UNITY ™ network.
The Solar 8000M System was developed to interface with third party peripheral devices that support serial and/or analeg 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/K012467 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012467: Solar 8000M System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012467
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026