Cleared Traditional

K944864 - PRIMED RIGID CONTAINER SYSTEM

K944864 is an FDA 510(k) clearance for PRIMED RIGID CONTAINER SYSTEM, manufactured by Primed, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K944864 · Primed, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
78d
Days
Class 2
Risk

K944864 is an FDA 510(k) clearance for the PRIMED RIGID CONTAINER SYSTEM. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Primed, Inc. (Manchester, US). The FDA issued a Cleared decision on December 20, 1994 after a review of 78 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 Primed, Inc. devices

FDA 510(k) Submission Details - K944864

510(k) Number K944864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1994
Decision Date December 20, 1994
Days to Decision 78 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
51d faster than avg
Panel avg: 129d · This submission: 78d
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 243
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K944864.
RE-BAG MULTI-USE POUCH, LARGE & SMALL
K954185 · Miltex, Inc. · Dec 1995
AUTO SUTURE* STERILIZATION TRAY**
K954090 · United States Surgical, A Division of Tyco Healthc · Nov 1995
STERRAD STERILIZATION POUCH
K951295 · Advanced Sterilization Products · May 1995
BARRIER PLASTIC PACKAGING (MODIFICATION)
K933560 · Maxxim Medical · Apr 1994
SHAVE PREP TRAY
K935739 · Cush Medical Products · Feb 1994
CAM-WRAP(TM) NEW STERILIZATION PROCEDURE
K891983 · Medical Dynamics, Inc. · Apr 1989