510(k) · Cleared
Recalled · Class II · 2012Spacelabs Pathfinder SL Holter 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 Jun 14, 2011 as substantially equivalent to K993620 (Del Mar Medical Systems, LLC, 1999) and 2 other predicates after a 162-day review. Its family tree reaches back 5 generations to 1991. 6 later devices descend from it. It has been recalled once.
- Decided
- Jun 14, 2011
- Review
- 162 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K910870 (1991). 12 ancestors in all, the oldest K871344 (1987). 6 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK910870 Edentec Model 3711 Digital RecorderEdentec Corp. · 1991
- 4 generations backK963597 Silent Night ILocal Silence, Inc. · 1997
- 3 generations backK981034 Silent Night IISleep Solutions, Inc. · 1998
- 2 generations backK000253 Silent Night VSleep Solutions, Inc. · 2000
- 1 generation backK042745 Lifescreen ApneaDel Mar Reynolds Medical, Inc. · 2005 · Recalled
- This deviceK110001 Spacelabs Pathfinder SL Holter AnalyzerSpacelabs Healthcare, Ltd. · 2011
- Descendant · cites it directly · 4 of its ownK110569 Audicor Cpam (Cardiopulmonary Ambulatory Monitor)Inovise Medical, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK120462 Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep…Inovise Medical, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK131883 Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK201921 Spacelabs Lifescreen PRO AnalyzerSpacelabs Healthcare, Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK151433 AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K110569Audicor Cpam (Cardiopulmonary Ambulatory Monitor)Inovise Medical, Inc. · 2011 · cites it directly4descendants
- K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…Inovise Medical, Inc. · 2012 · cites it directly3descendants
- K131883Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc. · 2014 · 2 generations on1descendant
- K201921Spacelabs Lifescreen PRO AnalyzerSpacelabs Healthcare, Ltd. · 2021 · cites it directly0descendants
- K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910870 | Edentec Model 3711 Digital Recorder | Edentec Corp. | 1991 | — |
| −4 | K963597 | Silent Night I | Local Silence, Inc. | 1997 | — |
| −3 | K981034 | Silent Night II | Sleep Solutions, Inc. | 1998 | — |
| −2 | K000253 | Silent Night V | Sleep Solutions, Inc. | 2000 | — |
| −1 | K042745 | Lifescreen Apnea | Del Mar Reynolds Medical, Inc. | 2005 | 1 |
| 0 (this device) | K110001 | Spacelabs Pathfinder SL Holter Analyzer | Spacelabs Healthcare, Ltd. | 2011 | — |
| +1 | K110569 | Audicor Cpam (Cardiopulmonary Ambulatory Monitor) | Inovise Medical, Inc. | 2011 | — |
| +1 | K120462 | Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep… | Inovise Medical, Inc. | 2012 | — |
| +2 | K131883 | Audicor Cpam with SDB (Accelerometer Based) | Inovise Medical, Inc. | 2014 | — |
| +1 | K201921 | Spacelabs Lifescreen PRO Analyzer | Spacelabs Healthcare, Ltd. | 2021 | — |
| +3 | K151433 | AUDICOR CA300/CC100 Analyzer with SDB | Inovise Medical, Inc. | 2016 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K993620 | ImpresarioSummary page 2…te Predicate Equivalent Devices: 510(k) Number Manufacturer/IModel Spacelabs Pathfinder SL K993620 Spacelabs (Del Mar Hotter Analyzer Medical Systems)… | 1999 |
| * | K951902 | Pathfinder 700 Holter AnalyzerSummary page 2…ECG (Holter) Arrhythma Analysis Software K95 1902 Spacelabs (Reynolds Medical Ltd) Pathfinder… | 1996 |
| * | K042745 | Lifescreen ApneaSummary page 2…edical Ltd) Pathfinder 700 Holter Analyzer K042745 Spacelabs (Del Mar Reynolds Medical, Inc.)… | 2005 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 11, 2012 | Class II | Z-1831-2012 | Software design | The firm received reports of the Pathfinder LS software crashing after editing a batch of Holter Analyzer records. The software will stop with an error message requiring a restart. In addition, QTc values will not update after moving the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K110569 (Inovise Medical, Inc., 2011) has gone furthest, with 4 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. 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 Pathfinder SL Holter Analyzer is intended to be used to analyze recordings of ambulatory electrocardiograms made on compatible Holter recorders. It is capable of detecting certain abnormal arrhythmias, and allows the operator to view and edit the ECG and the analysis results, and construct a report for physician use. The Spacelabs Pathfinder SL Holter Analyzer is intended for use on adult patients only as a screening device to determine the…
Read the full statement (129 words)
The Spacelabs Pathfinder SL Holter Analyzer is intended to be used to analyze recordings of ambulatory electrocardiograms made on compatible Holter recorders. It is capable of detecting certain abnormal arrhythmias, and allows the operator to view and edit the ECG and the analysis results, and construct a report for physician use.
The Spacelabs Pathfinder SL Holter Analyzer is intended for use on adult patients only as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score. The ECG recording may be obtained at any location specified by a physician including home, hospital or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110001 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110001: Spacelabs Pathfinder SL Holter Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110001
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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