Cleared Traditional

K854891 - KNIFE

K854891 is an FDA 510(k) clearance for KNIFE, manufactured by Euro-Med Intl.. The device is a Class 1 General & Plastic Surgery device with product code EMF cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K854891 · Euro-Med Intl. · General & Plastic Surgery device
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May 1986
Decision
147d
Days
Class 1
Risk

K854891 is an FDA 510(k) clearance for the KNIFE. Classified as Knife, Surgical (product code EMF), Class I - General Controls.

Submitted by Euro-Med Intl. (Danville, US). The FDA issued a Cleared decision on May 2, 1986 after a review of 147 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Euro-Med Intl. devices

FDA 510(k) Submission Details - K854891

510(k) Number K854891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1985
Decision Date May 02, 1986
Days to Decision 147 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
32d slower than avg
Panel avg: 115d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

EMF Device Classification - Class 1, General Controls

Product Code EMF Knife, Surgical
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 - EMF Knife, Surgical

All 14
Devices cleared under the same product code (EMF) and FDA review panel - the closest regulatory comparables to K854891.
VAN-TEC ENDOPYELOTOMY KNIFE
K880094 · Van-Tec, Inc. · Feb 1988
VALTRAC (BAR) REMOVER DEVICE
K863752 · Davis & Geck, Inc. · Oct 1986
REUSABLE/DISPOSABLE AUTOPSY KNIFE SET
K863549 · Surgipath Medical Industries, Inc. · Sep 1986
27-210 PLASTER KNIFE (REINER)
K851784 · Artiberia · Jun 1985
VALVOTOMY KNIFE
K843371 · Downs Surgical , Ltd. · Oct 1984
H.R. JAKOBI SURG. INSTRUMENTS #11 38/67
K834184 · Imm Enterprises , Ltd. · Jan 1984