Cleared Traditional

K974638 - STERITITE SEALED CONTAINERS MODEL SCO4Q

K974638 is an FDA 510(k) clearance for STERITITE SEALED CONTAINERS MODEL SCO4Q, 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 69-day FDA review.

K974638 · Case Medical, Inc. · General Hospital
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Dec 1997
Decision
69d
Days
Class 2
Risk

K974638 is an FDA 510(k) clearance for the STERITITE SEALED CONTAINERS MODEL SCO4Q. 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 December 18, 1997 after a review of 69 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 - K974638

510(k) Number K974638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1997
Decision Date December 18, 1997
Days to Decision 69 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 129d · This submission: 69d
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 K974638.
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
G.E. STERILE, STANDARD BIOPSY TRAY
K960141 · GE Medical Systems · Feb 1996
G.E. STERILE BREAST BIOPSY/LOCALIZATION TRAY
K960201 · GE Medical Systems · Feb 1996