Cleared Traditional

K861530 - SURGICAL PACKS

K861530 is an FDA 510(k) clearance for SURGICAL PACKS, manufactured by Medical Concepts Development, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FSM cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K861530 · Medical Concepts Development, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
36d
Days
Class 1
Risk

K861530 is an FDA 510(k) clearance for the SURGICAL PACKS, KITS AND TRAYS. Classified as Tray, Surgical, Instrument (product code FSM), Class I - General Controls.

Submitted by Medical Concepts Development, Inc. (St. Paul, US). The FDA issued a Cleared decision on May 30, 1986 after a review of 36 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Medical Concepts Development, Inc. devices

FDA 510(k) Submission Details - K861530

510(k) Number K861530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received April 24, 1986
Decision Date May 30, 1986
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

FSM Device Classification - Class 1, General Controls

Product Code FSM Tray, Surgical, Instrument
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FSM Tray, Surgical, Instrument

All 22
Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K861530.
STERILE LACERATION TRAY CAT. #749
K900479 · Busse Hospital Disposables, Inc. · Feb 1990
STERILIZATION TRAY, TMJ INSTRUMENT SET
K871924 · Arthropedics, Inc. · Jun 1987
MEDSURG PERCUTANEOUS ASPIRATION BIOPSY (PAB) TRAY
K870892 · Medsurg Industries, Inc. · Apr 1987
VENESECTION TRAY, ADULT 6050
K843627 · Pro-Lab, Inc. · Dec 1984
HANDI-TRAY
K823438 · Treace Medical, Inc. · Jan 1983
OPERATING ROOM KIT
K811916 · American Hospital Supply Corp. · Oct 1981