Cleared Traditional

K162162 - Barrier Supreme Sterilization Wrapper

K162162 is an FDA 510(k) clearance for Barrier Supreme Sterilization Wrapper, manufactured by Standard Textile Co., Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K162162 · Standard Textile Co., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
94d
Days
Class 2
Risk

K162162 is an FDA 510(k) clearance for the Barrier Supreme Sterilization Wrapper. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Standard Textile Co., Inc. (Cincinnati, US). The FDA issued a Cleared decision on November 4, 2016 after a review of 94 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - 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.

View all Standard Textile Co., Inc. devices

FDA 510(k) Submission Details - K162162

510(k) Number K162162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2016
Decision Date November 04, 2016
Days to Decision 94 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 129d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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.

Regulatory Consultant

Hogan Lovells US LLP
Jonathan Kahan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRG Wrap, Sterilization

All 226
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K162162.
Cardinal Health Sterilization Wrap
K161910 · Cardinal Health200, LLC · Apr 2017
SteriTite Containers System & MediTray Products
K161415 · Case Medical, Inc. · Feb 2017
PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator
K160595 · Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti · Nov 2016
Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators
K153540 · Safe Secure Packaging Co., Ltd. · Aug 2016
Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
K160755 · Ahlstrom Nonwovens, LLC · Jul 2016
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K160908 · STERIS Corporation · Jul 2016