Cleared Traditional

K152669 - PMSSteripack Self-Seal Sterilization Po...

K152669 is an FDA 510(k) clearance for PMSSteripack Self-Seal Sterilization Po..., manufactured by Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K152669 · Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std · General Hospital
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Optimized for regulatory review, auditing and printing
Jan 2016
Decision
120d
Days
Class 2
Risk

K152669 is an FDA 510(k) clearance for the PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP). Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std (Mersin, TR). The FDA issued a Cleared decision on January 15, 2016 after a review of 120 days - within the typical 510(k) review window.

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 Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std devices

FDA 510(k) Submission Details - K152669

510(k) Number K152669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2015
Decision Date January 15, 2016
Days to Decision 120 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
9d faster than avg
Panel avg: 129d · This submission: 120d
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 180
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K152669.
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K160908 · STERIS Corporation · Jul 2016
Gemini Sterilization Wrap
K152564 · Medline Industries, Inc. · Jul 2016
Gemini Bonded Sterilization Wrap
K152458 · Medline Industries, Inc. · Jun 2016
Cardinal Health Sterilization Wrap
K151445 · Cardinal Health200, LLC · Dec 2015
Sterisheet Sterilization Wrap
K152291 · Andersen Sterilizers, Inc. · Dec 2015
Gemini Sterilization Wrap
K150698 · Medline Industries, Inc. · Nov 2015