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The Tracker / October 2026 / K261679

510(k) cleared

BlineSlide

Deep Breathe, Inc. · Oct 23, 2026 · K261679

FDA cleared the BlineSlide from Deep Breathe, Inc. on Oct 23, 2026 under K261679, a traditional 510(k). The device falls under product code POK, Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer, regulated at 21 CFR 892.2060 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 21, 2026. The decision came 155 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Deep Breathe, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261679?

K261679 is the FDA 510(k) for BlineSlide, submitted by Deep Breathe, Inc.. FDA's decision date was Oct 23, 2026, under product code POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer).

Who makes the BlineSlide?

Deep Breathe, Inc., based in London, is the applicant of record for K261679.

How long did the K261679 review take?

FDA received the submission on May 21, 2026 and issued its decision on Oct 23, 2026, 155 days later.

← All decisions in October 2026