Cleared Traditional

K833343 - STERILIZATION CONTAINER

K833343 is an FDA 510(k) clearance for STERILIZATION CONTAINER, manufactured by Medin Corp.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K833343 · Medin Corp. · General Hospital
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Nov 1983
Decision
37d
Days
Class 2
Risk

K833343 is an FDA 510(k) clearance for the STERILIZATION CONTAINER. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Medin Corp. (Walker, US). The FDA issued a Cleared decision on November 3, 1983 after a review of 37 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 Medin Corp. devices

FDA 510(k) Submission Details - K833343

510(k) Number K833343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1983
Decision Date November 03, 1983
Days to Decision 37 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 129d · This submission: 37d
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 240
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K833343.
DRESSING CHANGE TRAY
K841123 · Medcare Products · Apr 1984
VANTAGE E
K841156 · American Sterilizer Co. · Apr 1984
JAKOBI SURG. INSTRUMENTS #2 70/71
K834193 · Imm Enterprises , Ltd. · Feb 1984
PRO-GUARD
K830739 · Surgicot, Inc. · Mar 1983
EAGLE STERISET
K823902 · American Sterilizer Co. · Jan 1983
ECONOMY LINE OF TRAYS
K820589 · Abco Dealers, Inc. · Apr 1982