Cleared Traditional

K821485 - DERMABRADERS

K821485 is an FDA 510(k) clearance for DERMABRADERS, manufactured by Spire Medical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GFF cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K821485 · Spire Medical, Inc. · General & Plastic Surgery device
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Jun 1982
Decision
23d
Days
Class 1
Risk

K821485 is an FDA 510(k) clearance for the DERMABRADERS. Classified as Bur, Surgical, General & Plastic Surgery (product code GFF), Class I - General Controls.

Submitted by Spire Medical, Inc. (Ventura, US). The FDA issued a Cleared decision on June 10, 1982 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 878.4820 - 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 Spire Medical, Inc. devices

FDA 510(k) Submission Details - K821485

510(k) Number K821485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1982
Decision Date June 10, 1982
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.

GFF Device Classification - Class 1, General Controls

Product Code GFF Bur, Surgical, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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 - GFF Bur, Surgical, General & Plastic Surgery

All 7
Devices cleared under the same product code (GFF) and FDA review panel - the closest regulatory comparables to K821485.
MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR
K862852 · Micro-Aire Surgical Instruments, Inc. · Aug 1986
MICRO-AIRE GENERIC BURS & DRILLS
K850497 · Micro-Aire Surgical Instruments, Inc. · Mar 1985
HOLE CHAMFERING DEVICE
K841298 · Techmedica, Inc. · Apr 1984
MICRO-AIRE REPLACEMENT DRILL BURS
K820281 · Micro-Aire Surgical Instruments, Inc. · Feb 1982