Cleared Traditional

K993764 - MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH

K993764 is an FDA 510(k) clearance for MEDIPACK SEE-THROUGH SEAL STERILIZATION..., manufactured by Medipack Medical Packaging Mfg. Co.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K993764 · Medipack Medical Packaging Mfg. Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
38d
Days
Class 2
Risk

K993764 is an FDA 510(k) clearance for the MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Medipack Medical Packaging Mfg. Co. (Potomac, US). The FDA issued a Cleared decision on December 16, 1999 after a review of 38 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 Medipack Medical Packaging Mfg. Co. devices

FDA 510(k) Submission Details - K993764

510(k) Number K993764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1999
Decision Date December 16, 1999
Days to Decision 38 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
91d faster than avg
Panel avg: 129d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KCT Device Classification - Class 2, Special Controls

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
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 - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 202
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K993764.
MILTEX RIGID STERILIZATION CONTAINER SYSTEM
K050570 · Miltex, Inc. · Jul 2005
PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE
K042062 · Bard Peripheral Vascular, Inc. · Sep 2004
OLYMPUS STERILIZATION TRAYS
K033222 · Olympus Winter & Ibe GmbH · Aug 2004
CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS
K972719 · Medicel, S.A. DE C.V. · Feb 1999
C/T MED-SYSTEMS CASSETTE SYSTEM
K980065 · C/T Med System, Ltd. · May 1998
KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION
K973827 · Kimberly-Clark Corp. · Feb 1998