Cleared Traditional

K103210 - TYVEK SELF-SEAL POUCHES WITH STERRAD

K103210 is the FDA 510(k) clearance for TYVEK SELF-SEAL POUCHES WITH STERRAD by Advanced Sterilization Products. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K103210 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
217d
Days
Class 2
Risk

K103210 is an FDA 510(k) clearance for the TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SE.... 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 June 6, 2011 after a review of 217 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

Submission Details

510(k) Number K103210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2010
Decision Date June 06, 2011
Days to Decision 217 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
88d slower than avg
Panel avg: 129d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 112
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K103210.
GEMINI STERILZATION WRAP
K113353 · Medline Industries, Inc. · Jan 2013
KIMGUARD ONE-STEP STERILIZATION WRAP
K112805 · Kimberly-Clark Corp. · Jun 2012
KIMGUARD SMART-FOLD* STERILIZATION WRAP
K112300 · Kimberly-Clark Corp. · Jan 2012
AESCULAP STERILCONTAINER S
K093493 · Aesculap, Inc. · Jul 2010
KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600
K092167 · Kimberly-Clark Corp. · Nov 2009
KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600
K091685 · Kimberly-Clark Corp. · Sep 2009