510(k) · Cleared
ClearedSpacelabs Lifescreen PRO Analyzer
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 Mar 26, 2021 as substantially equivalent to K110001 (Spacelabs Healthcare, Ltd., 2011) after a 259-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Mar 26, 2021
- Review
- 259 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K910870 (1991). 13 ancestors in all, the oldest K871344 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK910870 Edentec Model 3711 Digital RecorderEdentec Corp. · 1991
- 5 generations backK963597 Silent Night ILocal Silence, Inc. · 1997
- 4 generations backK981034 Silent Night IISleep Solutions, Inc. · 1998
- 3 generations backK000253 Silent Night VSleep Solutions, Inc. · 2000
- 2 generations backK042745 Lifescreen ApneaDel Mar Reynolds Medical, Inc. · 2005 · Recalled
- 1 generation backK110001 Spacelabs Pathfinder SL Holter AnalyzerSpacelabs Healthcare, Ltd. · 2011 · Recalled
- This deviceK201921 Spacelabs Lifescreen PRO AnalyzerSpacelabs Healthcare, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K910870 | Edentec Model 3711 Digital Recorder | Edentec Corp. | 1991 | — |
| −5 | K963597 | Silent Night I | Local Silence, Inc. | 1997 | — |
| −4 | K981034 | Silent Night II | Sleep Solutions, Inc. | 1998 | — |
| −3 | K000253 | Silent Night V | Sleep Solutions, Inc. | 2000 | — |
| −2 | K042745 | Lifescreen Apnea | Del Mar Reynolds Medical, Inc. | 2005 | 1 |
| −1 | K110001 | Spacelabs Pathfinder SL Holter Analyzer | Spacelabs Healthcare, Ltd. | 2011 | 1 |
| 0 (this device) | K201921 | Spacelabs Lifescreen PRO Analyzer | Spacelabs Healthcare, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 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 |
|---|---|---|---|
| * | K110001 | Spacelabs Pathfinder SL Holter AnalyzerSummary page 4…elabs Predicate Predicate Equivalent Devices: Model 510(k) Number Manufacturer / Model Spacelabs Lifescreen K110001 Spacelabs Pathfinder SL PRO Analyzer K201921… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- 3 of the 13 ancestors have a recall of any class.
- 2 other devices also cite its predicate K110001.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Lifescreen PRO Analyzer (Model 98800 Analyzer) is intended to be used to analyze recordings of ambulatory electrocardiograms made on compatible ECG recorders. Lifescreen PRO is capable of analyzing the ECG, detecting certain arrhythmias, allowing the user to view and edit analysis results, correlating symptomatic patient events and construct a report for use by Physicians / Cardiologists.
Lifescreen PRO can be used as a triage tool for assessment of ambulatory ECG from supported devices; supporting selection and export of ECG segments for more detailed analysis in the Spacelabs Pathfinder SL Analyzer.
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/K201921 · printed Nov 5, 2026
Cite this page
510(k) Report. “K201921: Spacelabs Lifescreen PRO Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K201921
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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