Cleared Traditional

K160595 - PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator

K160595 is an FDA 510(k) clearance for PMSSteripack Tyvek Sterilization Pouch ..., manufactured by Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K160595 · Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
262d
Days
Class 2
Risk

K160595 is an FDA 510(k) clearance for the PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indic.... Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti (Mersin, TR). The FDA issued a Cleared decision on November 18, 2016 after a review of 262 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.

FDA 510(k) Submission Details - K160595

510(k) Number K160595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2016
Decision Date November 18, 2016
Days to Decision 262 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
133d slower than avg
Panel avg: 129d · This submission: 262d
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 261
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K160595.
Self Sealing Sterilization Pouches
K162258 · Tianchang Jiarui Packaging Material Co., Ltd. · Apr 2017
Cardinal Health Sterilization Wrap
K161910 · Cardinal Health200, LLC · Apr 2017
SteriTite Containers System & MediTray Products
K161415 · Case Medical, Inc. · Feb 2017
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
Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
K160755 · Ahlstrom Nonwovens, LLC · Jul 2016