Cleared Traditional

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

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

K071087 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K071087

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.

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 321
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K071087.
STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
K080558 · Case Medical, Inc. · Dec 2008
TSO3 OZONE STERILIZATION WRAP
K080198 · Tso3, Inc. · May 2008
SELF SEAL STERILIZATION POUCH
K071886 · Shanghai Jianzhong Medical Packaging Co., Ltd. · Dec 2007
STERILIZATION POUCH WITH INDICATORS
K062704 · Winner Industries (Shenzhen) Co., Ltd. · Jun 2007
ARJOWRAP 47/100 AND 47/88
K062100 · Arjo Wiggins Medical, Inc. · Dec 2006
AESCULAP STERILCONTAINER SYSTEM
K062510 · Aesculap · Nov 2006
K071087 · VIS-U-ALL II HEAT-SEAL POUCH AND TUBING
Download PDF FDA Summary STERIS Corporation