Cleared Traditional

K162362 - PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator

K162362 is an FDA 510(k) clearance for PMSSteripack Flat Sterilization Pouch (..., manufactured by Pms Tibbi Cihazlar Teknolojisi San VE Tic AS. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 416-day FDA review.

K162362 · Pms Tibbi Cihazlar Teknolojisi San VE Tic AS · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
416d
Days
Class 2
Risk

K162362 is an FDA 510(k) clearance for the PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Pms Tibbi Cihazlar Teknolojisi San VE Tic AS (Mersin, TR). The FDA issued a Cleared decision on October 13, 2017 after a review of 416 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Pms Tibbi Cihazlar Teknolojisi San VE Tic AS devices

FDA 510(k) Submission Details - K162362

510(k) Number K162362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2016
Decision Date October 13, 2017
Days to Decision 416 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
287d slower than avg
Panel avg: 129d · This submission: 416d
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 260
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K162362.
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K172749 · STERIS Corporation · Feb 2018
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
Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
K171533 · Ahlstrom Nonwovens, LLC · Jun 2017
Gemini Sterilization Wrap
K162993 · Medline Industries, Inc. · Jun 2017