510(k) · Cleared
ClearedPreemptiveAI Clinical SDK
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Measure Labs, Inc. (Dba Preemptiveai, Inc.) · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Feb 13, 2026 as substantially equivalent to K232804 (Qompium NV, 2024) after a 382-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Feb 13, 2026
- Review
- 382 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K963725 (1997). 10 ancestors in all, the oldest K920984 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 5 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 4 generations backK052767 Afibalert Atrial Fibrillation DetectorLechnologies Research, Inc. · 2006
- 3 generations backK132206 Melys Atrial Fibrillation Screening MonitorAdvanced Fluidics, LLC · 2014
- 2 generations backK173872 FibriCheckQompium NV · 2018
- 1 generation backK232804 FibriCheckQompium NV · 2024
- This deviceK250233 PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.) · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −5 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −4 | K052767 | Afibalert Atrial Fibrillation Detector | Lechnologies Research, Inc. | 2006 | — |
| −3 | K132206 | Melys Atrial Fibrillation Screening Monitor | Advanced Fluidics, LLC | 2014 | — |
| −2 | K173872 | FibriCheck | Qompium NV | 2018 | — |
| −1 | K232804 | FibriCheck | Qompium NV | 2024 | — |
| 0 (this device) | 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 |
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 DXH? 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 DXH device
- #1 K243438 MEMO Patch M (MPT-E08R-UNC01)score 12.9 · 9 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 |
|---|---|---|---|
| * | K232804 | FibriCheckSummary page 5…nsmitter and receiver Product Code: DXH Regulatory Class: II Predicate Device: Fibricheck (K232804) Indications for Use: The PreemptiveAI Clinical SDK is intended for noninvasive spot measurement of p… | 2024 |
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 29 years and passes through 6 companies; a new generation was cleared every 4.8 years on median.
- None of the 10 ancestors has a recall.
How does its category compare?
All DXH devicesDXH Transmitters And Receivers, Electrocardiograph, Telephone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · DXH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXH
322in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXH
27in 2025
MAUDE reports naming product code DXH, 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 | 3 | 202 | 0 | 0 |
| 2008 | 7 | 41 | 4 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 0 | — | 3 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 3 | 206 | 0 | 1 |
| 2014 | 6 | 186 | 0 | 1 |
| 2015 | 4 | 142 | 1 | 0 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 5 | 150 | 0 | 4 |
| 2018 | 4 | 294 | 0 | 0 |
| 2019 | 6 | 177 | 0 | 0 |
| 2020 | 5 | 141 | 0 | 5 |
| 2021 | 3 | 107 | 0 | 2 |
| 2022 | 4 | 150 | 0 | 6 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 4 | 322 | 0 | 27 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The PreemptiveAI Clinical SDK is intended for noninvasive spot measurement of pulse rate. The measurement is based on video recording of the subject’s fingertip using a smartphone camera. It is designed for use when the subject is still. It is indicated for individuals 18 years of age or older not requiring critical care or continuous vital signs monitoring. It is not intended for use in patients with known or suspected heart arrhythmias.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250233: PreemptiveAI Clinical SDK.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250233
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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