Cleared Traditional

K173349 - Operio (FDA 510(k) Clearance)

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

K173349 · Toul Meditech AB · General Hospital
Dec 2017
Decision
56d
Days
Class 2
Risk

K173349 is an FDA 510(k) clearance for the Operio. Classified as Air Filter Portable Apparatus (product code ORC), Class II - Special Controls.

Submitted by Toul Meditech AB (Vasteras, SE). The FDA issued a Cleared decision on December 20, 2017 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.5070 - the FDA general hospital 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.

Submission Details

510(k) Number K173349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2017
Decision Date December 20, 2017
Days to Decision 56 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 169d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ORC Air Filter Portable Apparatus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5070
Definition The Sytem Is Intended To Control The Surgical Environment To Prevent Bacterial Contamination During Surgical Procedures.
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 General Hospital devices follow this clearance model.