Cleared Traditional

K874439 - SOFT TISSUE ANCHORING SET KIT

K874439 is an FDA 510(k) clearance for SOFT TISSUE ANCHORING SET KIT, manufactured by Concept, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LRO cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K874439 · Concept, Inc. · General & Plastic Surgery device
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Nov 1987
Decision
23d
Days
Class 2
Risk

K874439 is an FDA 510(k) clearance for the SOFT TISSUE ANCHORING SET KIT. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Concept, Inc. (Clearwater, US). The FDA issued a Cleared decision on November 20, 1987 after a review of 23 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 Concept, Inc. devices

FDA 510(k) Submission Details - K874439

510(k) Number K874439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1987
Decision Date November 20, 1987
Days to Decision 23 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 115d · This submission: 23d
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 34
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K874439.
BIOPSY KIT
K892389 · I M, Inc. · Jul 1989
HOMER MAMMALOK LOCALIZATION SHIELD
K885090 · North American Instrument Corp. · Feb 1989
ALCON SURGICAL PROCEDURE PACKS
K880961 · Alcon Laboratories · Apr 1988
CLOSED CHEST DRAINAGE SET
K871873 · Gish Biomedical, Inc. · Jul 1987
MEDSURG ARTHROGRAM TRAY
K854292 · Medsurg Industries, Inc. · Nov 1985
GENERAL SURGERY TRAY
K842648 · Deroyal Industries, Inc. · Sep 1984