Cleared Traditional

K061033 - MILTEX RIGID STERILIZATION CONTAINER SYSTEM

K061033 is an FDA 510(k) clearance for MILTEX RIGID STERILIZATION CONTAINER SYSTEM, manufactured by Miltex, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K061033 · Miltex, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Dec 2006
Decision
242d
Days
Class 2
Risk

K061033 is an FDA 510(k) clearance for the MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS). Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Miltex, Inc. (York, US). The FDA issued a Cleared decision on December 12, 2006 after a review of 242 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 Miltex, Inc. devices

FDA 510(k) Submission Details - K061033

510(k) Number K061033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2006
Decision Date December 12, 2006
Days to Decision 242 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
113d slower than avg
Panel avg: 129d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KCT Device Classification - Class 2, Special Controls

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 171
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K061033.
MILTEX RIGID CONTAINER SYSTEMS
K072563 · Miltex, Inc. · Feb 2008
VIS-U-ALL II SELF SEAL POUCH
K070765 · STERIS Corporation · Oct 2007
VHP 136 TRAY
K070769 · STERIS Corporation · Oct 2007
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS
K051157 · Micromedics, Inc. · Sep 2005
MILTEX RIGID STERILIZATION CONTAINER SYSTEM
K050570 · Miltex, Inc. · Jul 2005
PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE
K042062 · Bard Peripheral Vascular, Inc. · Sep 2004