510(k) · Decided
DecidedSpacelabs Medical Ecg Analysis System
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 Apr 25, 1997 as substantially equivalent to K844940 (Spacelabs, Inc., 1985) and 2 other predicates after a 270-day review. Its family tree reaches back 1 generation to 1985. 2 later devices descend from it.
- Decided
- Apr 25, 1997
- Review
- 270 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K844940 (1985). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK844940 Spacelabs Model 90201 Holter RecorderSpacelabs, Inc. · 1985
- This deviceK962930 Spacelabs Medical Ecg Analysis SystemSpacelabs Medical, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK063490 Spacelabs Medical Full Disclosure System, Model 91810Spacelabs Medical, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK110779 Spacelabs Smart Disclosure SystemSpacelabs Healthcare · 2011 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K844940 | Spacelabs Model 90201 Holter Recorder | Spacelabs, Inc. | 1985 | — |
| 0 (this device) | K962930 | Spacelabs Medical Ecg Analysis System | Spacelabs Medical, Inc. | 1997 | — |
| +1 | K063490 | Spacelabs Medical Full Disclosure System, Model 91810 | Spacelabs Medical, Inc. | 2007 | 1 |
| +2 | 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 |
|---|---|---|
| 2007 | 1 | 0 |
| 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 26.6 · 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? (3)
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 |
|---|---|---|---|
| * | K844940 | Spacelabs Model 90201 Holter RecorderSummary page 1…cally, SpaceLabs Medical believes that the ECG Recorder component of the system is substantially equivalent to the predicate SpacelLabs Medical ECG Recorder Model 90205 (K844940), which utilizes an analog cassefte tape storage system and the Zymed Model 3100 DigiTrak ECG/Pacer Recorder (K942781), which inc… | 1985 |
| * | K942781 | Digital Holter RecorderSummary page 1…dicate SpacelLabs Medical ECG Recorder Model 90205 (K844940), which utilizes an analog cassefte tape storage system and the Zymed Model 3100 DigiTrak ECG/Pacer Recorder (K942781), which incorporates a solid state flash memory card for data storage. The Cardiology Workstation component of the SpacelLabs Me… | 1995 |
| * | K895208 | Zymed Model 1610Summary page 1…ory card for data storage. The Cardiology Workstation component of the SpacelLabs Medical ECG Analysis System is substantially equivalent to the Model 1610 Workstation (K895208) currently marketed by Zymed Corporation in that both products provide for the loading and analysis of up to 3-channel ECG data a… | 1989 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063490 | Spacelabs Medical Full Disclosure System, Model 91810 | 2007 | 1 |
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K063490 (Spacelabs Medical, Inc., 2007) has gone furthest, with 1 descendant 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.
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 Cardiology Workstation is intended for use with the SpacelLabs Medical ECC Recorder to provide for the analysis of ambulatory ECG data. After the recording is made on the ECG Recorder, the Cardiology Workstation analyzes the ECG waveform data for the duration of the recording and produces a series of reports summarizing the overall activity on the recording and highlighting significant clinical events. The system provides for review…
Read the full statement (129 words)
The Spacelabs Medical Cardiology Workstation is intended for use with the SpacelLabs Medical ECC Recorder to provide for the analysis of ambulatory ECG data. After the recording is made on the ECG Recorder, the Cardiology Workstation analyzes the ECG waveform data for the duration of the recording and produces a series of reports summarizing the overall activity on the recording and highlighting significant clinical events. The system provides for review of the automated analysis and for a qualified user to make editing changes to the automated results.
The Cardiology Workstation can also receive input from an analog-based cassette tape ambulatory recorder and an infrared serial link, as well as from the SpacelLabs PCMS monitoring network to provide for the collection, review, editing, printing and archiving of waveform data records.
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/K962930 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962930: Spacelabs Medical Ecg Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962930
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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