Cleared Traditional

K171533 - Reliance Solo Sterilization Wrap

K171533 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 35-day FDA review.

K171533 · Ahlstrom Nonwovens, LLC · General Hospital
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Jun 2017
Decision
35d
Days
Class 2
Risk

K171533 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 June 29, 2017 after a review of 35 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ahlstrom Nonwovens, LLC devices

FDA 510(k) Submission Details - K171533

510(k) Number K171533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2017
Decision Date June 29, 2017
Days to Decision 35 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 129d · This submission: 35d
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 Peers - FRG Wrap, Sterilization

All 180
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K171533.
Sterisheet Sterilization Wrap
K170437 · Andersen Sterilizers, Inc. · Nov 2017
Tyvek Sterilization Pouches with Chevron Seal
K170429 · Andersen Sterilizers, Inc. · Oct 2017
Standard Supreme Sterilization Wrapper
K172207 · Standard Textile Co., Inc. · Aug 2017
Gemini Sterilization Wrap
K162993 · Medline Industries, Inc. · Jun 2017
Cardinal Health Sterilization Wrap
K161910 · Cardinal Health200, LLC · Apr 2017
Barrier Supreme Sterilization Wrapper
K162162 · Standard Textile Co., Inc. · Nov 2016