510(k) · Cleared
Recalled · 2008Spacelabs Medical Full Disclosure System, Model 91810
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs Medical, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Mar 15, 2007 as substantially equivalent to K962930 (Spacelabs Medical, Inc., 1997) after a 118-day review. Its family tree reaches back 2 generations to 1985. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 15, 2007
- Review
- 118 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K844940 (1985). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK844940 Spacelabs Model 90201 Holter RecorderSpacelabs, Inc. · 1985
- 1 generation backK962930 Spacelabs Medical Ecg Analysis SystemSpacelabs Medical, Inc. · 1997
- This deviceK063490 Spacelabs Medical Full Disclosure System, Model 91810Spacelabs Medical, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK110779 Spacelabs Smart Disclosure SystemSpacelabs Healthcare · 2011 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K110779Spacelabs Smart Disclosure SystemSpacelabs Healthcare · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K844940 | Spacelabs Model 90201 Holter Recorder | Spacelabs, Inc. | 1985 | — |
| −1 | K962930 | Spacelabs Medical Ecg Analysis System | Spacelabs Medical, Inc. | 1997 | — |
| 0 (this device) | K063490 | Spacelabs Medical Full Disclosure System, Model 91810 | Spacelabs Medical, Inc. | 2007 | — |
| +1 | K110779 | Spacelabs Smart Disclosure System | Spacelabs Healthcare | 2011 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K962930 | Spacelabs Medical Ecg Analysis SystemSummary page 3…496 Test The Spacelabs Medical Full Disclosure System, Model 91810 and the Discussion: Spacelabs Medical ECG analysis system, model 91810, K962930 are substantially equivalent in design concepts, technologies and materials. The Full Dis… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110779 | Spacelabs Smart Disclosure System | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 17, 2008 | Not classified | Z-2270-2010 | Device Design | Potential for device to print out the wrong waveform data for the time indicated in the printout or display. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 12.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K110779 (Spacelabs Healthcare, 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Medical Full Disclosure System 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. The Full Disclosure System 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 Medical Full Disclosure System is to interface with the Spacelabs monitoring network in order to provide the user with a means of recalling waveform information and retrospectively analyzing up to 72 hours of monitoring patient's most recent ECG waveform data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063490 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063490: Spacelabs Medical Full Disclosure System, Model 91810.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063490
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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