Cleared Traditional

K890215 - MICROSURGICAL SCARIFIER

K890215 is an FDA 510(k) clearance for MICROSURGICAL SCARIFIER, manufactured by Kinetic Medical Products. The device is a Class 1 General & Plastic Surgery device with product code EMF cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K890215 · Kinetic Medical Products · General & Plastic Surgery device
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Jan 1989
Decision
9d
Days
Class 1
Risk

K890215 is an FDA 510(k) clearance for the MICROSURGICAL SCARIFIER. Classified as Knife, Surgical (product code EMF), Class I - General Controls.

Submitted by Kinetic Medical Products (Erie, US). The FDA issued a Cleared decision on January 27, 1989 after a review of 9 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 Kinetic Medical Products devices

FDA 510(k) Submission Details - K890215

510(k) Number K890215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1989
Decision Date January 27, 1989
Days to Decision 9 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
106d faster than avg
Panel avg: 115d · This submission: 9d
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 10
Devices cleared under the same product code (EMF) and FDA review panel - the closest regulatory comparables to K890215.
MICROSURGERY RAZOR BLADE HOLDER
K890214 · Kinetic Medical Products · Jan 1989
MICROSURGICAL KNIVES
K890217 · Kinetic Medical Products · Jan 1989
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