Cleared Traditional

K070765 - VIS-U-ALL II SELF SEAL POUCH

K070765 is the FDA 510(k) clearance for VIS-U-ALL II SELF SEAL POUCH by STERIS Corporation. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K070765 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
206d
Days
Class 2
Risk

K070765 is an FDA 510(k) clearance for the VIS-U-ALL II SELF SEAL POUCH. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on October 12, 2007 after a review of 206 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all STERIS Corporation devices

Submission Details

510(k) Number K070765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2007
Decision Date October 12, 2007
Days to Decision 206 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
77d slower than avg
Panel avg: 129d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
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 - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 161
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K070765.
SMITH & NEPHEW INSTRUMENT TRAYS
K090562 · Smith & Nephew, Inc. · Mar 2009
AESCULAP PRIMELINE CONTAINER LTD.
K073168 · Aesculap, Inc. · Apr 2008
INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS
K072211 · Intuitive Surgical, Inc. · Feb 2008
VHP 136 TRAY
K070769 · STERIS Corporation · Oct 2007
OLYMPUS STERILIZATION TRAYS
K033222 · Olympus Winter & Ibe GmbH · Aug 2004
KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION
K973827 · Kimberly-Clark Corp. · Feb 1998