PreemptiveAI Clinical SDK— 510(k) K250233
Substantially EquivalentMeasure Labs, Inc. (Dba Preemptiveai, Inc.)
FDA 510(k) clearance K250233 for PreemptiveAI Clinical SDK, Substantially Equivalent on 2026-02-13. Applicant: Measure Labs, Inc. (Dba Preemptiveai, Inc.). Device class: 2.
Summary
Measure Labs, doing business as PreemptiveAI, filed the PreemptiveAI Clinical SDK under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone). The record doesn't describe the SDK beyond its name and that code name.
Class II, 21 CFR 870.2920. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).
Measure Labs filed from Seattle, Washington. Review took 382 calendar days (January 27, 2025 to February 13, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Measure Labs, Inc. (Dba Preemptiveai, Inc.)
- Product code
- Product code DXH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2920
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seattle, WA, US
Recent devices under product code DXH
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