510(k) · Cleared
Recalled · Class II · 2019Spacelabs Smart Disclosure System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs Healthcare · DQK Computer, Diagnostic, Programmable
Cleared on Apr 19, 2011 as substantially equivalent to K063490 (Spacelabs Medical, Inc., 2007) after a 29-day review. Its family tree reaches back 3 generations to 1985. It has been recalled 3 times.
- Decided
- Apr 19, 2011
- Review
- 29 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 3 generations to K844940 (1985). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK844940 Spacelabs Model 90201 Holter RecorderSpacelabs, Inc. · 1985
- 2 generations backK962930 Spacelabs Medical Ecg Analysis SystemSpacelabs Medical, Inc. · 1997
- 1 generation backK063490 Spacelabs Medical Full Disclosure System, Model 91810Spacelabs Medical, Inc. · 2007 · Recalled
- This deviceK110779 Spacelabs Smart Disclosure SystemSpacelabs Healthcare · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K844940 | Spacelabs Model 90201 Holter Recorder | Spacelabs, Inc. | 1985 | — |
| −2 | K962930 | Spacelabs Medical Ecg Analysis System | Spacelabs Medical, Inc. | 1997 | — |
| −1 | K063490 | Spacelabs Medical Full Disclosure System, Model 91810 | Spacelabs Medical, Inc. | 2007 | 1 |
| 0 (this device) | K110779 | Spacelabs Smart Disclosure System | Spacelabs Healthcare | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 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 26.7 · 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? (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 |
|---|---|---|---|
| * | K063490 | Spacelabs Medical Full Disclosure System, Model 91810Summary page 1…edicate Equivalent Devices: 5i 0(k-) Number Manufacturer/Model Spacelabs Smart Disclosure K063490 Spacelabs Medical Inc./ System, Model 928 10 Full Disclosure… | 2007 |
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 |
|---|---|---|---|---|
| Jan 28, 2019 | Class II | Z-2035-2019 | Software design | Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms. |
| Feb 14, 2014 | Class II | Z-1273-2014 | Labeling Change Control | Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed on the Clinical Access CD are incorrect and it will prevent the customer from installing Clinical Access. |
| Dec 5, 2012 | Class II | Z-0694-2013 | Software design | Displaying or printing of an incorrect waveform for the time indicated in the printout or display in the Spacelabs Healthcare Intesys Clinical Suite (ICS) G2, Version 4.03, Clinical Access portion of Smart Disclosure, Model 92810. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
- 1 of the 5 ancestors has 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. 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 Spacelabs Smart Disclosure System, Model 92810 is indicated for use in clinical situations where there is a need for review of physiological waveform information and alarm events up to 72 hours after the fact. Smart Disclosure is also indicated in those situations where a retrospective analysis of monitoring patients' ECG waveform data, that can be annotated and edited, is desired. The intended use of the Spacelabs Smart Disclosure is to interface…
Read the full statement (114 words)
The Spacelabs Smart Disclosure System, Model 92810 is indicated for use in clinical situations where there is a need for review of physiological waveform information and alarm events up to 72 hours after the fact. Smart Disclosure is also indicated in those situations where a retrospective analysis of monitoring patients' ECG waveform data, that can be annotated and edited, is desired.
The intended use of the Spacelabs Smart Disclosure is to interface with the Spacelabs monitoring network, providing the user with a means of recalling waveform information and performing retrospective analysis. The most recent 72 hours of monitored patient ECG waveform data can be analyzed, with each analysis limited to 24 hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110779 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110779: Spacelabs Smart Disclosure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110779
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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