Cleared Traditional

K170429 - Tyvek Sterilization Pouches with Chevro...

K170429 is an FDA 510(k) clearance for Tyvek Sterilization Pouches with Chevro..., manufactured by Andersen Sterilizers, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K170429 · Andersen Sterilizers, Inc. · General Hospital
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Oct 2017
Decision
256d
Days
Class 2
Risk

K170429 is an FDA 510(k) clearance for the Tyvek Sterilization Pouches with Chevron Seal. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Andersen Sterilizers, Inc. (Haw River, US). The FDA issued a Cleared decision on October 27, 2017 after a review of 256 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 Andersen Sterilizers, Inc. devices

FDA 510(k) Submission Details - K170429

510(k) Number K170429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2017
Decision Date October 27, 2017
Days to Decision 256 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
127d slower than avg
Panel avg: 129d · This submission: 256d
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 150
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K170429.
Sterilization Pouch/Roll Made with Tyvek
K180672 · Sigma Medical Supplies Corporation · Jun 2018
SIGMA Sterilization Pouch and Roll
K180661 · Sigma Medical Supplies Corp. · Jun 2018
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K172749 · STERIS Corporation · Feb 2018
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