Cleared Special

Steriking® LT-Blueline Pouches with Tyvek® (K231996) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K231996 · Wipak OY · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
64d
Days
Class 2
Risk

K231996 is an FDA 510(k) clearance for the Steriking® LT-Blueline Pouches with Tyvek®. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Wipak OY (Nastola, FI). The FDA issued a Cleared decision on September 7, 2023 after a review of 64 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Wipak OY devices

Submission Details

510(k) Number K231996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2023
Decision Date September 07, 2023
Days to Decision 64 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 129d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

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 89
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K231996.
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
K233777 · Primed Medical Products, Inc. · May 2024
Dukal SMS Sterilization Wrap
K233262 · Dukal, LLC · Mar 2024
Reliance® Fusion Sterilization Wraps
K230137 · Ahlstrom-Munksjo Nonwovens, LLC · Dec 2023
Steriking® LT-Blueline Pouches with Tyvek®
K231999 · Wipak OY · Sep 2023
Sterilization Wrap
K223600 · Wuhan Zonsen Medical Products Co., Ltd. · Aug 2023
Vis-U-All Low Temperature Sterilization Pouches
K231500 · STERIS Corporation · Aug 2023