Cleared Traditional

K190027 - SteriStay (FDA 510(k) Clearance)

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

K190027 · Toul Meditech AB · General & Plastic Surgery device
May 2019
Decision
123d
Days
Class 2
Risk

K190027 is an FDA 510(k) clearance for the SteriStay. 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 May 10, 2019 after a review of 123 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5070 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K190027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2019
Decision Date May 10, 2019
Days to Decision 123 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 132d · This submission: 123d
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 & Plastic Surgery devices follow this clearance model.