Cleared Traditional

K231500 - Vis-U-All Low Temperature Sterilization...

K231500 is the FDA 510(k) clearance for Vis-U-All Low Temperature Sterilization... by STERIS Corporation. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K231500 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
75d
Days
Class 2
Risk

K231500 is an FDA 510(k) clearance for the Vis-U-All Low Temperature Sterilization Pouches. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on August 7, 2023 after a review of 75 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all STERIS Corporation devices

Submission Details

510(k) Number K231500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2023
Decision Date August 07, 2023
Days to Decision 75 days
Submission Type Traditional
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
54d faster than avg
Panel avg: 129d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K231500.
Steriking® LT-Blueline Pouches with Tyvek®
K231996 · Wipak OY · Sep 2023
Steriking® LT-Blueline Pouches with Tyvek®
K231999 · Wipak OY · Sep 2023
Sterilization Wrap
K223600 · Wuhan Zonsen Medical Products Co., Ltd. · Aug 2023
Tyvek Roll with CI for STERLINK Sterilizer
K223025 · Plasmapp Co,., Ltd. · May 2023
Sterilization Wrap
K222151 · Kenpax International Limited · Mar 2023
Sterilization Pouch and Roll
K221875 · Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. · Feb 2023