Cleared Traditional

K071087 - VIS-U-ALL II HEAT-SEAL POUCH AND TUBING

K071087 is the FDA 510(k) clearance for VIS-U-ALL II HEAT-SEAL POUCH AND TUBING by STERIS Corporation. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K071087 · STERIS Corporation · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 2007
Decision
182d
Days
Class 2
Risk

K071087 is an FDA 510(k) clearance for the VIS-U-ALL II HEAT-SEAL POUCH AND TUBING. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on October 16, 2007 after a review of 182 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 K071087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2007
Decision Date October 16, 2007
Days to Decision 182 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
53d slower than avg
Panel avg: 129d · This submission: 182d
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 K071087.
KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600
K091685 · Kimberly-Clark Corp. · Sep 2009
KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600
K082554 · Kimberly-Clark Corp. · May 2009
KIMGUARD ONE-STEP STERILIZATION WRAP
K082177 · Kimberly-Clark Corp. · Mar 2009
AESCULAP STERILCONTAINER SYSTEM
K053389 · Aesculap, Inc. · Feb 2006
REUSABLE STERILCONTAINER FILTER MODEL #JK090
K041623 · Aesculap, Inc. · Dec 2004
APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER
K013003 · Advanced Sterilization Products · Aug 2002