Cleared Traditional

K871322 - ADVANCED MEDICAL SYSTEMS, KIT

K871322 is an FDA 510(k) clearance for ADVANCED MEDICAL SYSTEMS, manufactured by The Jarid Group, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LRO cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K871322 · The Jarid Group, Inc. · General & Plastic Surgery device
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May 1987
Decision
54d
Days
Class 2
Risk

K871322 is an FDA 510(k) clearance for the ADVANCED MEDICAL SYSTEMS, KIT. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by The Jarid Group, Inc. (Wayside, US). The FDA issued a Cleared decision on May 27, 1987 after a review of 54 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 The Jarid Group, Inc. devices

FDA 510(k) Submission Details - K871322

510(k) Number K871322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1987
Decision Date May 27, 1987
Days to Decision 54 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
61d faster than avg
Panel avg: 115d · This submission: 54d
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 K871322.
MEDICAL PACKET, INDIVIDUAL SURVIVAL KIT, AIRMAN'S
K871434 · Fraass Survival Systems, Inc. · Jul 1987
SURVIVAL KIT, INDIVIDUAL
K871437 · Fraass Survival Systems, Inc. · Jul 1987
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