BlineSlide

K252007

Deep Breathe, Inc. · cleared 2025-10-06 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.7)
“Blineslide is a cloud service application that helps qualified users with image-based assessment of lung ultrasound (LUS) cines acquired from the anterior or anterolateral chest regions during a physician-led LUS examination of patients aged 18 years or older. It does not directly interface with ultrasound systems.”
AlgorithmAI-assisted tool for detecting the presence or absence of B line artifacts in LUS cines; Ultrasound image processing software implementing artificial intelligence including non-adaptive machine learning algorithms trained with clinical data
source quote (p.7)
“B Line Artifact Module: an AI-assisted tool for detecting the presence or absence of B line artifacts in LUS cines”
Adaptive (vs locked)No
source quote (p.9)
“non-adaptive machine learning algorithms”
PCCPNo
Cybersecurity addressedYes
source quote (p.12)
“A comprehensive cybersecurity assessment was performed in accordance with FDA's premarket cybersecurity guidance and industry best practices. The device underwent penetration testing, vulnerability scanning, and a Common Vulnerabilities and Exposures (CVE) analysis. Identified threats were reviewed and mitigated using accepted controls, and no unmitigated high-severity vulnerabilities remained at the time of release.”

Validation studies (1)

Retrospective clinical

n=1,005 cases

endpoints: sensitivity; specificity

standards: ISO 14971

Reported performance (2 observations)

sensitivity0.91CI 0.88 – 0.94
source quote (p.12)
“0.91 (0.88 – 0.94)”
specificity0.84CI 0.81 – 0.86
source quote (p.12)
“0.84 (0.81 – 0.86)”

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
3
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 Radiology 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/K252007