Cleared Traditional

K991023 - STERITITE PERFORATED BOTTOM RIGID REUSA...

K991023 is an FDA 510(k) clearance for STERITITE PERFORATED BOTTOM RIGID REUSA..., 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 304-day FDA review.

K991023 · Case Medical, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Jan 2000
Decision
304d
Days
Class 2
Risk

K991023 is an FDA 510(k) clearance for the STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WIT.... Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Case Medical, Inc. (Washington, US). The FDA issued a Cleared decision on January 27, 2000 after a review of 304 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K991023

510(k) Number K991023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1999
Decision Date January 27, 2000
Days to Decision 304 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
175d slower than avg
Panel avg: 129d · This submission: 304d
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 K991023.
MEDLINE STERILIZATION WRAP
K002968 · Medline Industries, Inc. · Jan 2001
ALLEGIANCE GENESIS CONTAINER SYSTEM
K983299 · Allegiance Healthcare Corp. · Aug 2000
BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP
K993871 · Allegiance Healthcare Corp. · Apr 2000
BIOSHIELD EXPRESS STERILIZATION WRAP
K983719 · Allegiance Healthcare Corp. · Aug 1999
SUPRASHIELD EXPRESS STERILIZATION WRAP
K990300 · Allegiance Healthcare Corp. · Feb 1999
G.E. STERILE, PERCUTANEOUS CHOLANGIOGRAPHIC TRAY
K960204 · GE Medical Systems · Feb 1996