Cleared Traditional

InSee

K241152 · Tidal Medical Technologies, LLC · Anesthesiology
Aug 2025
Decision
482d
Days
Class 2
Risk

About This 510(k) Submission

K241152 is an FDA 510(k) clearance for the InSee, a Spirometer, Therapeutic (incentive) (Class II — Special Controls, product code BWF), submitted by Tidal Medical Technologies, LLC (San Francisco, US). The FDA issued a Cleared decision on August 21, 2025, 482 days after receiving the submission on April 26, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5690.

Submission Details

510(k) Number K241152 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2024
Decision Date August 21, 2025
Days to Decision 482 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BWF — Spirometer, Therapeutic (incentive)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5690