Cleared Traditional

K834558 - CK10000 SERIES POUCH & BAGS ETC.

K834558 is an FDA 510(k) clearance for CK10000 SERIES POUCH & BAGS ETC., manufactured by Currie Medical Specialties, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K834558 · Currie Medical Specialties, Inc. · General Hospital
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Sep 1984
Decision
252d
Days
Class 2
Risk

K834558 is an FDA 510(k) clearance for the CK10000 SERIES POUCH & BAGS ETC.. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Currie Medical Specialties, Inc. (Walker, US). The FDA issued a Cleared decision on September 5, 1984 after a review of 252 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Currie Medical Specialties, Inc. devices

FDA 510(k) Submission Details - K834558

510(k) Number K834558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1983
Decision Date September 05, 1984
Days to Decision 252 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
123d slower than avg
Panel avg: 129d · This submission: 252d
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 231
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K834558.
CAM-WRAP(TM) NEW STERILIZATION PROCEDURE
K891983 · Medical Dynamics, Inc. · Apr 1989
THE KEYMED FIBERSCOPE STERILIZATION CASE
K860528 · Keymed, Inc. · Jul 1986
MICROVASIVE SILICONE SPRAY
K854063 · Microvasive · Oct 1985
INSTRUMENT GUARD CAPSULE
K831588 · Treace Medical, Inc. · Jun 1983
DISPOSABLE INSTRUMENT TRAY PAD
K791412 · Anago, Inc. · Aug 1979
DISPOSABLE SURGICAL INSTRUMENT TIP
K782144 · Anago, Inc. · Jan 1979