PreemptiveAI Clinical SDK

K250233

Measure Labs, Inc. (Dba Preemptiveai, Inc.) · cleared 2026-02-13 · product code DXH · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“The PreemptiveAI Clinical SDK is a Software as a Medical Device (SaMD) that utilizes a smartphone to noninvasively measure pulse rate (PR).”
Algorithmproprietary deep learning algorithm; locked deep learning model
source quote (p.6)
“A proprietary deep learning algorithm then calculates pulse rate for every window that passes the quality screen. The SDK comprises a mobile SDK for integration into a 3rd-party app, backend server, and locked deep learning model for pulse rate prediction.”
Adaptive (vs locked)No
source quote (p.6)
“The SDK comprises a mobile SDK for integration into a 3rd-party app, backend server, and locked deep learning model for pulse rate prediction.”
PCCPNo
Cybersecurity addressedYes
source quote (p.8)
“Cybersecurity Testing - Cybersecurity testing was conducted including vulnerability analysis. Documentation was provided to show adequate cybersecurity measures have been taken and will be monitored and updated throughout the device life cycle.”

Validation studies (2)

Bench

sample size not stated

endpoints: accuracy across its claimed 50–125 bpm operational range; fail-safe behavior; appropriate algorithm behavior in the presence of heart arrhythmias

Retrospective clinical

n=111 patients

endpoints: noninvasive pulse rate measurement; substantial equivalence to the predicate device; accuracy within +/- 3 BPM ARMS

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

1
recalls in product code, 24mo
28
MAUDE reports in code, 12mo
+950%
vs code's own 3-yr baseline
2
drift signals on this device
  • adverse_event_inflection

    MAUDE adverse-event reports for product code DXH: 28 in the 12 months ending 2026-06, vs a 2.7/12mo average over the prior 3 windows (+950%). Code-level count — reports are not attributed to this specific device.

    first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=DXH

  • recall_reason_pattern

    Software/algorithm-related recall in product code DXH (GE Medical Systems China Co., Ltd. No. 19 Changjiang Road Development Zone National Hi-Tech Xin District Wuxi China, initiated 2026-04-21): "Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. " Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98917

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K250233