Cleared Special

K090371 - VIS-U-ALL LOW TEMPERATURE TYVEK STERILI...

K090371 is the FDA 510(k) clearance for VIS-U-ALL LOW TEMPERATURE TYVEK STERILI... by STERIS Corporation. It is a Class 2 General Hospital device (product code KCT) cleared through the Special 510(k) pathway after a 77-day FDA review.

K090371 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
77d
Days
Class 2
Risk

K090371 is an FDA 510(k) clearance for the VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION.... 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 May 1, 2009 after a review of 77 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 Corporation devices

Submission Details

510(k) Number K090371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2009
Decision Date May 01, 2009
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

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 160
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K090371.
GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS
K092682 · Gyrus Acmi, Inc. · Dec 2009
KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS
K090818 · KARL STORZ Endoscopy-America, Inc. · Aug 2009
SMITH & NEPHEW INSTRUMENT TRAYS
K091627 · Smith & Nephew, Inc. · Jul 2009
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