When did BlineSlide receive FDA clearance or approval?

BlineSlide (Submission ID: K261679) was fda cleared by the U.S. FDA on 2026-10-23 under the 510K pathway with a review duration of 155 days.

Who is the manufacturer or applicant for BlineSlide?

The applicant and sponsor for K261679 is Deep Breathe, Inc..

Yes. BlineSlide is classified as incorporating artificial intelligence or machine learning technology in the Radiology domain.

FDA Cleared New Device ✦ AI/ML Enabled (Radiology) Pathway: 510K

Applicant: Deep Breathe, Inc.

Legal Standard:

Substantial Equivalence (SE) to predicate (21 CFR 807)

Product Code:

POK

Review Panel:

Radiology

21 CFR Regulation:

Date Received:

2026-05-21

Decision Date:

2026-10-23

Total Review Duration:

155 calendar days (155 days)

Direct links to primary official records hosted by the U.S. Food and Drug Administration CDRH databases:

Robert Arntfield

Role: SUBMITTER_CONTACT

Notice a discrepancy or outdated information on this record?