510(k) · Cleared
ClearedFibriCheck
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qompium NV · QME Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
Cleared on Jun 7, 2024 as substantially equivalent to K173872 (Qompium NV, 2018) after a 269-day review. Its family tree reaches back 5 generations to 1997. 1 later device descends from it.
- Decided
- Jun 7, 2024
- Review
- 269 days
- Class
- Class II
- Product code
- QME
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K963725 (1997). 9 ancestors in all, the oldest K920984 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 4 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 3 generations backK052767 Afibalert Atrial Fibrillation DetectorLechnologies Research, Inc. · 2006
- 2 generations backK132206 Melys Atrial Fibrillation Screening MonitorAdvanced Fluidics, LLC · 2014
- 1 generation backK173872 FibriCheckQompium NV · 2018
- This deviceK232804 FibriCheckQompium NV · 2024
- Descendant · cites it directly · 0 of its ownK250233 PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.) · 2026
Most influential descendants
Showing 1 of 1 · See all- K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.) · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −4 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −3 | K052767 | Afibalert Atrial Fibrillation Detector | Lechnologies Research, Inc. | 2006 | — |
| −2 | K132206 | Melys Atrial Fibrillation Screening Monitor | Advanced Fluidics, LLC | 2014 | — |
| −1 | K173872 | FibriCheck | Qompium NV | 2018 | — |
| 0 (this device) | K232804 | FibriCheck | Qompium NV | 2024 | — |
| +1 | K250233 | PreemptiveAI Clinical SDK | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 QME? 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 QME device
- #1 K211906 Vital Signsscore 28.7 · 1 generation · 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 |
|---|---|---|---|
| * | K173872 | FibriCheckSummary page 5…ber 870.2920 Product Code DXH | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K173872 FibriCheck DXH Device Description Summary 21 CFR 807.92(a)(4) FibriCheck is a medical device software that can be used to determ… | 2018 |
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 |
|---|---|---|---|
| K250233 | PreemptiveAI Clinical SDK | 2026 | 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?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K250233 (Measure Labs, Inc. (Dba Preemptiveai, Inc.), 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K173872.
How does its category compare?
All QME devicesQME Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QME
4so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QME
266in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QME
No recall names QME since 2007.
Adverse event reports per year · QME
No MAUDE report names QME since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 3 | 266 | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 4 | 190 | 0 | — |
What is it indicated for?
FibriCheck is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing, atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.
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/K232804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232804: FibriCheck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232804
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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