Cleared Traditional

K181666 - Smart One (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181666 · Mir Medical International Research · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
37d
Days
Class 2
Risk

K181666 is an FDA 510(k) clearance for the Smart One. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Mir Medical International Research (Roma, IT). The FDA issued a Cleared decision on August 1, 2018 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1860 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mir Medical International Research devices

Submission Details

510(k) Number K181666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2018
Decision Date August 01, 2018
Days to Decision 37 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 139d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code BZH Meter, Peak Flow, Spirometry
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.