# K250233: PreemptiveAI Clinical SDK

- Pathway: 510(k) (Traditional)
- Applicant: Measure Labs, Inc. (Dba Preemptiveai, Inc.)
- Decided: Feb 13, 2026 after 382 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K963725 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232804: FibriCheck, Qompium NV (2024) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K250233
Methodology: https://510kreport.com/methodology