Cleared Traditional

K032445 - THE ULTRA SYSTEM

K032445 is an FDA 510(k) clearance for THE ULTRA SYSTEM, manufactured by Promedica, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K032445 · Promedica, Inc. · General Hospital
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Mar 2004
Decision
234d
Days
Class 2
Risk

K032445 is an FDA 510(k) clearance for the THE ULTRA SYSTEM. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Promedica, Inc. (Oldsmar, US). The FDA issued a Cleared decision on March 29, 2004 after a review of 234 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 Promedica, Inc. devices

FDA 510(k) Submission Details - K032445

510(k) Number K032445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2003
Decision Date March 29, 2004
Days to Decision 234 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 129d · This submission: 234d
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 209
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K032445.
MILTEX RIGID STERILIZATION CONTAINER SYSTEM
K050570 · Miltex, Inc. · Jul 2005
PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE
K042062 · Bard Peripheral Vascular, Inc. · Sep 2004
OLYMPUS STERILIZATION TRAYS
K033222 · Olympus Winter & Ibe GmbH · Aug 2004
MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH
K993764 · Medipack Medical Packaging Mfg. Co. · Dec 1999
CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS
K972719 · Medicel, S.A. DE C.V. · Feb 1999
C/T MED-SYSTEMS CASSETTE SYSTEM
K980065 · C/T Med System, Ltd. · May 1998