Cleared Traditional

K030853 - STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI

K030853 is an FDA 510(k) clearance for STERITITE PERFORATED BASE RIGID REUSABL..., 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 3-day FDA review.

K030853 · Case Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
3d
Days
Class 2
Risk

K030853 is an FDA 510(k) clearance for the STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH .... 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 March 21, 2003 after a review of 3 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Case Medical, Inc. devices

FDA 510(k) Submission Details - K030853

510(k) Number K030853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2003
Decision Date March 21, 2003
Days to Decision 3 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
126d faster than avg
Panel avg: 129d · This submission: 3d
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 245
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K030853.
STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS
K022978 · Case Medical, Inc. · May 2003
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
APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER
K013003 · Advanced Sterilization Products · Aug 2002
GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM
K012931 · Allegiance Healthcare Corp. · Aug 2002