Cleared Traditional

K160755 - Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap

K160755 is an FDA 510(k) clearance for Reliance Solo Sterilization Wrap, manufactured by Ahlstrom Nonwovens, LLC. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K160755 · Ahlstrom Nonwovens, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
131d
Days
Class 2
Risk

K160755 is an FDA 510(k) clearance for the Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Ahlstrom Nonwovens, LLC (Windsor Locks, US). The FDA issued a Cleared decision on July 27, 2016 after a review of 131 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.

FDA 510(k) Submission Details - K160755

510(k) Number K160755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2016
Decision Date July 27, 2016
Days to Decision 131 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
2d slower than avg
Panel avg: 129d · This submission: 131d
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

Ajw Technology Consultants, Inc.
LAUREN CHRAPOWITZKY

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 261
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K160755.
PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator
K160595 · Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti · Nov 2016
Barrier Supreme Sterilization Wrapper
K162162 · Standard Textile Co., Inc. · Nov 2016
Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators
K153540 · Safe Secure Packaging Co., Ltd. · Aug 2016
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K160908 · STERIS Corporation · Jul 2016
Gemini Sterilization Wrap
K152564 · Medline Industries, Inc. · Jul 2016
Gemini Bonded Sterilization Wrap
K152458 · Medline Industries, Inc. · Jun 2016