Cleared Traditional

THE ULTRA SYSTEM SP (K032813) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K032813 · Promedica, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
157d
Days
Class 2
Risk

K032813 is an FDA 510(k) clearance for the THE ULTRA SYSTEM SP. 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 February 13, 2004 after a review of 157 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

Submission Details

510(k) Number K032813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2003
Decision Date February 13, 2004
Days to Decision 157 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
28d slower than avg
Panel avg: 129d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 133
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K032813.
INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS
K072211 · Intuitive Surgical, Inc. · Feb 2008
VIS-U-ALL II SELF SEAL POUCH
K070765 · STERIS Corporation · Oct 2007
VHP 136 TRAY
K070769 · STERIS Corporation · Oct 2007
AUTO SUTURE* STERILIZATION TRAY**
K954090 · United States Surgical, A Division of Tyco Healthc · Nov 1995