Cleared Special

K031022 - PROTEC-TOP, STERIDENT, BENTO

K031022 is an FDA 510(k) clearance for PROTEC-TOP, manufactured by Ronpak, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Special 510(k) pathway after a 14-day FDA review.

K031022 · Ronpak, Inc. · General Hospital
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Apr 2003
Decision
14d
Days
Class 2
Risk

K031022 is an FDA 510(k) clearance for the PROTEC-TOP, STERIDENT, BENTO. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Ronpak, Inc. (South Plainfield, US). The FDA issued a Cleared decision on April 14, 2003 after a review of 14 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.

FDA 510(k) Submission Details - K031022

510(k) Number K031022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2003
Decision Date April 14, 2003
Days to Decision 14 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

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 321
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K031022.
TIDI BRAND STERILIZATION WRAP
K042580 · Banta Healthcare Group, Ltd. · Nov 2004
PACKAGING TRAY AND COMPONENTS
K040707 · Vygon Us, LLC · Apr 2004
STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS
K022978 · Case Medical, Inc. · May 2003
STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM
K023614 · Case Medical, Inc. · Apr 2003
STERILIZATION CASES AND TRAYS
K023658 · Carr Metal Products, Inc. · Mar 2003
STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI
K030853 · Case Medical, Inc. · Mar 2003
K031022 · PROTEC-TOP, STERIDENT, BENTO
Download PDF Ronpak, Inc.