Cleared Special

K222440 - Vis-U-All Low Temperature Sterilization...

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

K222440 · Steris · General Hospital
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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.

View all Steris devices

Submission Details

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.

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 118
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K222440.
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Gemini Sterilization Wrap
K220365 · Medline Industries, LP · Oct 2022
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K191131 · Solidence Surgical Corporation · Aug 2022
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K214007 · Owens & Minor (O&M) Halyard, Inc. · Jul 2022
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K221016 · Wipak OY · May 2022