510(k) · Cleared
Recalled · Class II · 2025Sentinel Cardiology Information Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs Healthcare, Ltd. · DQK Computer, Diagnostic, Programmable
Cleared on Apr 1, 2016 as substantially equivalent to K062397 (Del Mar Reynolds Medical, Ltd., 2007) and 1 other predicate after a 184-day review. Its family tree reaches back 8 generations to 1984. It has been recalled 2 times.
- Decided
- Apr 1, 2016
- Review
- 184 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 8 generations to K842308 (1984). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 7 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
- 6 generations backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- 5 generations backK050614 Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2005 · Recalled
- 4 generations backK072502 Modification to: Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2007 · Recalled
- 3 generations backK083639 Muse Cardiology Information System with VmwareGe Medical Systems Information Technologies · 2009 · Recalled
- 2 generations backK110132 Muse Cardiology Information SystemGe Medical Systems Information Technologies, Inc. · 2011
- 1 generation backK130155 Muse Cardiology Information SystemGe Medical Systems Information Technologies, Inc. · 2013
- This deviceK152881 Sentinel Cardiology Information Management SystemSpacelabs Healthcare, Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K842308 | 12SSL-SC | Marquette Electronics, Inc. | 1984 | — |
| −7 | K980495 | Muse Cardiovascular Information System | Marquette Medical Systems, Inc. | 1998 | — |
| −6 | K992637 | Muse Cardiovascular Information System | General Electric Medical Systems Information Techn | 1999 | 1 |
| −5 | K050614 | Muse Cardiology Information System | Ge Medical Systems Information Technologies | 2005 | 1 |
| −4 | K072502 | Modification to: Muse Cardiology Information System | Ge Medical Systems Information Technologies | 2007 | 2 |
| −3 | K083639 | Muse Cardiology Information System with Vmware | Ge Medical Systems Information Technologies | 2009 | 1 |
| −2 | K110132 | Muse Cardiology Information System | Ge Medical Systems Information Technologies, Inc. | 2011 | — |
| −1 | K130155 | Muse Cardiology Information System | Ge Medical Systems Information Technologies, Inc. | 2013 | — |
| 0 (this device) | K152881 | Sentinel Cardiology Information Management System | Spacelabs Healthcare, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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 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 |
|---|---|---|---|
| * | K062397 | SentinelSummary page 5…Predicate Predicate Equivalent Devices: Model 510(k) Number Manufacturer / Model Sentinel Cardiology K062397 DelMar Reynalds Medical Ltd. Information Management (now part of Spacelabs… | 2007 |
| * | K130155 | Muse Cardiology Information SystemSummary page 5…(now part of Spacelabs System Healthcard Ltd.) / Sentinel K130155 GE Medical Systems Information Technologies /… | 2013 |
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 |
|---|---|---|---|---|
| Sep 16, 2025 | Class II | Z-0416-2026 | Software design | Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions… |
| Nov 6, 2020 | Class II | Z-0563-2021 | Software design | During system upgrade incorrect comments may be added to existing tests. In such instance: Resting ECG and ABP tests which did not contain comments at the time of the upgrade, may have unrelated comments added. Existing comments will not… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 13 ancestors have a recall of any class.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Sentinel Cardiology Information Management System is intended to connect to supported medical devices and analyzers in order to download, store, access and manage cardiovascular information and to manage patient and facility information. The Sentinel Cardiology Information Management System provides download and storage of data from supported Holter recorders and feeds this data to separate and optional Holter analyzers. The completed reports are…
Read the full statement (158 words)
The Sentinel Cardiology Information Management System is intended to connect to supported medical devices and analyzers in order to download, store, access and manage cardiovascular information and to manage patient and facility information.
The Sentinel Cardiology Information Management System provides download and storage of data from supported Holter recorders and feeds this data to separate and optional Holter analyzers. The completed reports are stored back in Sentinel.
The Sentinel Cardiology Information Management System facilitates presenting, analyzing, reviewing cardiovascular information, including automatic interpretation of 12 lead ECG and stores the finished reports. The automatic interpretation of 12-lead ECG is not suitable for neonates.
Sentinel supports importing reports from external systems and provides an HL7 interface to external systems.
The Sentinel Cardiology Information Management System is intended to be used by a trained user and as an aid to a medical professional in hospital or primary care environment.
The Sentinel Cardiology Information Management System is not intended for patient monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152881: Sentinel Cardiology Information Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152881
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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