Cleared Traditional

K153498 - Operio (FDA 510(k) Clearance)

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

K153498 · Toul Meditech AB · General Hospital
Jul 2016
Decision
226d
Days
Class 2
Risk

K153498 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 (Västerås, SE). The FDA issued a Cleared decision on July 20, 2016 after a review of 226 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K153498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2015
Decision Date July 20, 2016
Days to Decision 226 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 169d · This submission: 226d
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.