Cleared Traditional

K141693 - Tyvek® Pouch/Roll with STERRAD® Chemical Indicator

K141693 is an FDA 510(k) clearance for Tyvek Pouch/Roll with STERRAD Chemical ..., manufactured by Advanced Sterilization Products. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K141693 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
178d
Days
Class 2
Risk

K141693 is an FDA 510(k) clearance for the Tyvek® Pouch/Roll with STERRAD® Chemical Indicator. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on December 19, 2014 after a review of 178 days - an extended review 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: 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 Advanced Sterilization Products devices

FDA 510(k) Submission Details - K141693

510(k) Number K141693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2014
Decision Date December 19, 2014
Days to Decision 178 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
49d slower than avg
Panel avg: 129d · This submission: 178d
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 226
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K141693.
FLASHPAK STERILIZATION CONTAINER SYSTEM
K141826 · Symmetry Medical Inc- Manchester · Apr 2015
STERILIZATION POUCH/ROLL MADE WITH TYVEK
K133838 · Sigma Medical Supplies Corp. · Mar 2015
KIMGUARD ONE-STEP Sterilization Wrap
K142782 · Kimberly-Clark Health Care · Mar 2015
KIMGUARD ONE STEP STERILIZATION WRAP
K141712 · Halyard Health · Dec 2014
STERILUCENT SELF-SEAL STERILIZATION POUCH
K141412 · Gs Medical Packaging, Inc. · Dec 2014
KIMGUARD SMART-FOLD STERILIZATION WRAP
K140963 · Kimberly-Clark Corp. · Nov 2014