Cleared Traditional

K800311 - 450 DRILL/800 DRILL

K800311 is an FDA 510(k) clearance for 450 DRILL/800 DRILL, manufactured by Black & Decker(Tm). The device is a Class 1 Orthopedic device with product code KIJ cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K800311 · Black & Decker(Tm) · Orthopedic device
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Feb 1980
Decision
10d
Days
Class 1
Risk

K800311 is an FDA 510(k) clearance for the 450 DRILL/800 DRILL. Classified as Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment (product code KIJ), Class I - General Controls.

Submitted by Black & Decker(Tm) (Mchenry, US). The FDA issued a Cleared decision on February 22, 1980 after a review of 10 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 Black & Decker(Tm) devices

FDA 510(k) Submission Details - K800311

510(k) Number K800311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1980
Decision Date February 22, 1980
Days to Decision 10 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 122d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

KIJ Device Classification - Class 1, General Controls

Product Code KIJ Instrument, Surgical, Orthopedic, Dc-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 - KIJ Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment

All 17
Devices cleared under the same product code (KIJ) and FDA review panel - the closest regulatory comparables to K800311.
FLUTED SUCTION MENISCAL CUTTER
K850789 · T. Korossurgical Instruments Corp. · Jun 1985
MICRO-CRAFT OSCILLATING SAW HANDPIECE
K822790 · Xomed, Inc. · Oct 1982
INTRA-ARTICULAR SURGICAL SYSTEM
K820367 · Dyonics, Inc. · May 1982
DRILL, CORDLESS SURGICAL
K790063 · Richard'S Medical Equip., Inc. · Feb 1979
INTRA-ARTICULAR SHAVER
K771218 · Dyonics, Inc. · Feb 1978