Cleared Traditional

K022978 - STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS

K022978 is an FDA 510(k) clearance for STERITITE CONTAINER WITH FLASHTITE VALV..., 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 245-day FDA review.

K022978 · Case Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
245d
Days
Class 2
Risk

K022978 is an FDA 510(k) clearance for the STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & 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 May 9, 2003 after a review of 245 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 Case Medical, Inc. devices

FDA 510(k) Submission Details - K022978

510(k) Number K022978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2002
Decision Date May 09, 2003
Days to Decision 245 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
116d slower than avg
Panel avg: 129d · This submission: 245d
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 244
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K022978.
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TIDI BRAND STERILIZATION WRAP
K042580 · Banta Healthcare Group, Ltd. · Nov 2004
STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM
K023614 · Case Medical, Inc. · Apr 2003
STERILIZATION CASES AND TRAYS
K023658 · Carr Metal Products, Inc. · Mar 2003
SELF SEAL STERILIZATION POUCH
K023025 · Granton Medical , Ltd. · Mar 2003