prolaio eVO2peak Module (Version 1.0)

K252204

Prolaio, Inc. · cleared 2025-12-16 · product code PPW · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“The prolaio eVO2peak Module is a software-only Class II SaMD Python library.”
Algorithmlocked deep-learning model
source quote (p.6)
“The module applies a locked deep-learning model trained against reference VO2 Peak from cardiopulmonary exercise test (CPET).”
Adaptive (vs locked)No
source quote (p.10)
“The algorithm is locked and does not perform autonomous updates.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.10)
“Cybersecurity testing was conducted under the principles in FDA's 2023 Cybersecurity Premarket Guidance. The module includes encryption, access control, input validation, and logging as part of its secure product development framework. All residual risks post-mitigation were evaluated as acceptable.”

Validation studies (1)

Retrospective clinical

n=228 patients

standards: ISO 14971

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

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/K252204