Cleared Traditional

K852661 - APOLLO STERILE BLADES

K852661 is an FDA 510(k) clearance for APOLLO STERILE BLADES, manufactured by Orthofab, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GES cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K852661 · Orthofab, Inc. · General & Plastic Surgery device
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Jul 1985
Decision
17d
Days
Class 1
Risk

K852661 is an FDA 510(k) clearance for the APOLLO STERILE BLADES. Classified as Blade, Scalpel (product code GES), Class I - General Controls.

Submitted by Orthofab, Inc. (Cottage Grove, US). The FDA issued a Cleared decision on July 11, 1985 after a review of 17 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.

FDA 510(k) Submission Details - K852661

510(k) Number K852661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1985
Decision Date July 11, 1985
Days to Decision 17 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
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

GES Device Classification - Class 1, General Controls

Product Code GES Blade, Scalpel
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 - GES Blade, Scalpel

All 47
Devices cleared under the same product code (GES) and FDA review panel - the closest regulatory comparables to K852661.
SURGICAL BLADES
K854620 · Niraj Industries · Dec 1985
BLADE, SCALPEL
K854561 · Medelec Intl. Corp. · Dec 1985
STAINLESS STEEL & CARBON STEEL STERILE BLADES
K853528 · Abco Dealers, Inc. · Sep 1985
STERILE SURGICAL BLADES
K852141 · Miltex Instrument Co. · Jun 1985
SURGIMED - SURGICAL BLADES
K851157 · Surgimed Corp. · Apr 1985
SURGICAL SCALPEL BLADES & DISPOSABLES
K844759 · Cross Country Paper Products Corp. · Jan 1985
K852661 · APOLLO STERILE BLADES
Download PDF Orthofab, Inc.