Cleared Special

K222440 - Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays

K222440 is an FDA 510(k) clearance for Vis-U-All Low Temperature Sterilization..., manufactured by Steris. The device is a Class 2 General Hospital device with product code FRG cleared through the Special 510(k) pathway after a 28-day FDA review.

K222440 · Steris · General Hospital

Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)

Optimized for regulatory review, auditing and printing

Sep 2022

Decision

28d

Days

Class 2

Risk

K222440 is an FDA 510(k) clearance for the Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilizatio.... Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Steris (Mentor, US). The FDA issued a Cleared decision on September 9, 2022 after a review of 28 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 - K222440

510(k) Number	K222440 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 12, 2022
Decision Date	September 09, 2022
Days to Decision	28 days
Submission Type	Special
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

101d faster than avg

Panel avg: 129d · This submission: 28d

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 322

Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K222440.

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FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.