510(k) · Cleared
ClearedRespievents Software IS Event Data Processing Sofware for a PC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Non-Invasive Monitoring Systems, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Aug 21, 2001 as substantially equivalent to K001369 (Non-Invasive Monitoring Systems, Inc., 2000) after a 54-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Aug 21, 2001
- Review
- 54 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001369 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK001369 Respievents, Version 4.2Non-Invasive Monitoring Systems, Inc. · 2000
- This deviceK012020 Respievents Software IS Event Data Processing Sofware for a PCNon-Invasive Monitoring Systems, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK153654 Sentry WEB SmartInterpCarefusion Germany 234 GmbH · 2016
Most influential descendants
Showing 1 of 1 · See all- K153654Sentry WEB SmartInterpCarefusion Germany 234 GmbH · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001369 | Respievents, Version 4.2 | Non-Invasive Monitoring Systems, Inc. | 2000 | — |
| 0 (this device) | K012020 | Respievents Software IS Event Data Processing Sofware for a PC | Non-Invasive Monitoring Systems, Inc. | 2001 | — |
| +1 | K153654 | Sentry WEB SmartInterp | Carefusion Germany 234 GmbH | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K001369 | Respievents, Version 4.2Summary page 1…ification Name: Programmable Diagnostic Computer PREDICATE DEVICE: The legally marketed device to which equivalence is claimed is: RespiEvents™ software, Version 4.2, K001369, cleared on July 26, 2000. /7 % Product Code: 74 DQK & CFR Section: 870.1425 * DEVICE DESCRIPTION: RespiEvents™ is a softwa… | 2000 |
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 |
|---|---|---|---|
| K153654 | Sentry WEB SmartInterp | 2016 | 0 |
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?
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?
RespiEvents™ is a software package running on a personal computer that is intended to provide analysis of breathing patterns from RespiTrace technology, aid in identifying and classifying apneas, displaying heart rate changes from electrocardiographic waveforms, logging values from pulse oximetry, and displaying signals from physiologic recording devices such as a body position sensor and impedance pneumograph, in the wake and sleeping states as well as activities of daily living.
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/K012020 · printed Nov 3, 2026
Cite this page
510(k) Report. “K012020: Respievents Software IS Event Data Processing Sofware for a PC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K012020
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026