Cleared Traditional

K090068 - STERITITE UNIVERSAL CONTAINER SYSTEM AN...

K090068 is an FDA 510(k) clearance for STERITITE UNIVERSAL CONTAINER SYSTEM AN..., manufactured by Case Medical, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 411-day FDA review.

K090068 · Case Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
411d
Days
Class 2
Risk

K090068 is an FDA 510(k) clearance for the STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Case Medical, Inc. (Ridgefield, US). The FDA issued a Cleared decision on February 24, 2010 after a review of 411 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Case Medical, Inc. devices

FDA 510(k) Submission Details - K090068

510(k) Number K090068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2009
Decision Date February 24, 2010
Days to Decision 411 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
282d slower than avg
Panel avg: 129d · This submission: 411d
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 149
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K090068.
DURA BLUE STERILIZATION WRAP
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KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600
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