Cleared Traditional

K802105 - C-BLADE

K802105 is an FDA 510(k) clearance for C-BLADE, manufactured by Cutter Laboratories, Inc.. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K802105 · Cutter Laboratories, Inc. · Orthopedic device
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Sep 1980
Decision
13d
Days
Class 1
Risk

K802105 is an FDA 510(k) clearance for the C-BLADE. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Cutter Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - the FDA orthopedic device regulatory 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 Cutter Laboratories, Inc. devices

FDA 510(k) Submission Details - K802105

510(k) Number K802105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1980
Decision Date September 16, 1980
Days to Decision 13 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 122d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

HWE Device Classification - Class 1, General Controls

Product Code HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
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 - HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment

All 33
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K802105.
INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM
K854987 · Richard Wolf Medical Instruments Corp. · Feb 1986
DEXTRA PRECISION POWER SYSTEM
K853489 · Chattanooga Group, Inc. · Sep 1985
TORQUE PLUS CATALOG 30120
K833940 · Concept, Inc. · Dec 1983
INTRA-ARTICULATED EDGER-PLANER SYSTEM
K792353 · Richard Wolf Medical Instruments Corp. · Dec 1979
CHARNLEY FEMUR DRILL #1 AND #2
K760977 · Codman & Shurtleff, Inc. · Nov 1976