510(k) · Cleared
ClearedMuse Cardiology Information System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on May 25, 2011 as substantially equivalent to K072502 (Ge Medical Systems Information Technologies, 2007) and 1 other predicate after a 127-day review. Its family tree reaches back 6 generations to 1984. 15 later devices descend from it.
- Decided
- May 25, 2011
- Review
- 127 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K842308 (1984). 8 ancestors in all. 15 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 5 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
- 4 generations backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- 3 generations backK050614 Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2005 · Recalled
- 2 generations backK072502 Modification to: Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2007 · Recalled
- 1 generation backK083639 Muse Cardiology Information System with VmwareGe Medical Systems Information Technologies · 2009 · Recalled
- This deviceK110132 Muse Cardiology Information SystemGe Medical Systems Information Technologies, Inc. · 2011
- Descendant · cites it directly · 9 of its ownK133882 Carescape Central Station (Formally Known as Cic Pro)Ge Medical Systems Information Technologies, Inc. · 2014 · Recalled
- Descendant · cites it directly · 7 of its ownK162012 CARESCAPE Central Station V2GE Healthcare · 2016 · Recalled
- Descendant · 2 generations on · 3 of its ownK201941 Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK130155 Muse Cardiology Information SystemGe Medical Systems Information Technologies, Inc. · 2013
- Descendant · 3 generations on · 2 of its ownK213490 Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor…Ge Medical Systems Information Technologies, Inc. · 2022 · Recalled
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K133882Carescape Central Station (Formally Known as Cic Pro)Ge Medical Systems Information Technologies, Inc. · 2014 · cites it directly9descendants
- K162012CARESCAPE Central Station V2GE Healthcare · 2016 · cites it directly7descendants
- K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc. · 2020 · 2 generations on3descendants
- K130155Muse Cardiology Information SystemGe Medical Systems Information Technologies, Inc. · 2013 · cites it directly3descendants
- K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc. · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K842308 | 12SSL-SC | Marquette Electronics, Inc. | 1984 | — |
| −5 | K980495 | Muse Cardiovascular Information System | Marquette Medical Systems, Inc. | 1998 | — |
| −4 | K992637 | Muse Cardiovascular Information System | General Electric Medical Systems Information Techn | 1999 | 1 |
| −3 | K050614 | Muse Cardiology Information System | Ge Medical Systems Information Technologies | 2005 | 1 |
| −2 | K072502 | Modification to: Muse Cardiology Information System | Ge Medical Systems Information Technologies | 2007 | 2 |
| −1 | K083639 | Muse Cardiology Information System with Vmware | Ge Medical Systems Information Technologies | 2009 | 1 |
| 0 (this device) | K110132 | Muse Cardiology Information System | Ge Medical Systems Information Technologies, Inc. | 2011 | — |
| +1 | K133882 | Carescape Central Station (Formally Known as Cic Pro) | Ge Medical Systems Information Technologies, Inc. | 2014 | 1 |
| +1 | K162012 | CARESCAPE Central Station V2 | GE Healthcare | 2016 | 6 |
| +2 | K201941 | Monitor B125, Monitor B105 | Ge Medical Systems Information Technologies, Inc. | 2020 | — |
| +1 | K130155 | Muse Cardiology Information System | Ge Medical Systems Information Technologies, Inc. | 2013 | — |
| +3 | K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2022 | 6 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 4 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 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 |
|---|---|---|---|
| * | K072502 | Modification to: Muse Cardiology Information SystemSummary page 2…the same functional scientific technology as the predicate devices MUSE Cardiovascular Information System (K072502) and MUSE Cardiovascular Information System wI VMWare (K0… | 2007 |
| * | K083639 | Muse Cardiology Information System with VmwareSummary page 2…Cardiovascular Information System (K072502) and MUSE Cardiovascular Information System wI VMWare (K083639). Determination of Summary of Non-Clinical Tests: Substantial Equivalence: The MUSE Cardiology I… | 2009 |
What descends from it? (15)
See all 154 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?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K133882 (Ge Medical Systems Information Technologies, Inc., 2014) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K072502.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
The MUSE Cardiology Information System is intended to store, access and manage cardiovascular information on adult and pediatric patients. The information consists of measurements, text, and digitized waveforms. The MUSE Cardiology Information System provides the ability to review and edit electrocardiographic procedures on screen, through the use of reviewing, measuring, and editing tools including ECG serial comparison and interpretive 12-lead…
Read the full statement (115 words)
The MUSE Cardiology Information System is intended to store, access and manage cardiovascular information on adult and pediatric patients. The information consists of measurements, text, and digitized waveforms. The MUSE Cardiology Information System provides the ability to review and edit electrocardiographic procedures on screen, through the use of reviewing, measuring, and editing tools including ECG serial comparison and interpretive 12-lead analysis. The MUSE Cardiology Information System is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or facility providing patient care. The MUSE Cardiology Information System is not intended for real-time patient monitoring. The MUSE Cardiology Information System is not intended for pediatric serial comparison.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110132 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110132: Muse Cardiology Information System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110132
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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