Cleared Traditional

K874760 - CK 4900 SERIES, GOWN AND TOWEL PAK

K874760 is an FDA 510(k) clearance for CK 4900 SERIES, manufactured by Currie Medical Specialties, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LRO cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K874760 · Currie Medical Specialties, Inc. · General & Plastic Surgery device
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Dec 1987
Decision
21d
Days
Class 2
Risk

K874760 is an FDA 510(k) clearance for the CK 4900 SERIES, GOWN AND TOWEL PAK. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Currie Medical Specialties, Inc. (Monrovia, US). The FDA issued a Cleared decision on December 10, 1987 after a review of 21 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4370 - the FDA general and plastic surgery 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 Currie Medical Specialties, Inc. devices

FDA 510(k) Submission Details - K874760

510(k) Number K874760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1987
Decision Date December 10, 1987
Days to Decision 21 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRO Device Classification - Class 2, Special Controls

Product Code LRO General Surgery Tray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - LRO General Surgery Tray

All 67
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K874760.
KLEEN TEST O.R. KIT
K890098 · Kleen Test Products · Jan 1989
REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR/DRAPE/BAS.
K882684 · Standard Textile Co., Inc. · Aug 1988
ALCON SURGICAL PROCEDURE PACKS
K880961 · Alcon Laboratories · Apr 1988
SOFT TISSUE ANCHORING SET KIT
K874439 · Concept, Inc. · Nov 1987
BLOOD CONTAINMENT PACK
K872448 · Professional Medical Services · Nov 1987
MEDICAL PACKET, INDIVIDUAL SURVIVAL KIT, AIRMAN'S
K871434 · Fraass Survival Systems, Inc. · Jul 1987