Cleared Traditional

K871478 - SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS

K871478 is an FDA 510(k) clearance for SURGICAL PACKS, manufactured by Procedure Pak, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FSM cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K871478 · Procedure Pak, Inc. · General & Plastic Surgery device
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May 1987
Decision
23d
Days
Class 1
Risk

K871478 is an FDA 510(k) clearance for the SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS. Classified as Tray, Surgical, Instrument (product code FSM), Class I - General Controls.

Submitted by Procedure Pak, Inc. (Asheville, US). The FDA issued a Cleared decision on May 7, 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 878.4800 - 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 Procedure Pak, Inc. devices

FDA 510(k) Submission Details - K871478

510(k) Number K871478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1987
Decision Date May 07, 1987
Days to Decision 23 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
92d faster than avg
Panel avg: 115d · This submission: 23d
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 39
Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K871478.
HAND SURGERY AND IRRIGATION TRAY (MODEL 3625)
K900376 · Pmt Corp. · Apr 1990
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
SCANLAN (TM) INSTRUMENT TRAY
K864920 · Scanlan Intl., Inc. · Jan 1987
VENESECTION TRAY, ADULT 6050
K843627 · Pro-Lab, Inc. · Dec 1984