Cleared Traditional

OH-HARRIS (K801388) - FDA 510(k) Clearance

Class I Orthopedic device.

K801388 · Johnson & Johnson Professionals, Inc. · Orthopedic device
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Jul 1980
Decision
45d
Days
Class 1
Risk

K801388 is an FDA 510(k) clearance for the OH-HARRIS. Classified as Dispenser, Cement (product code KIH), Class I - General Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on July 28, 1980 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4200 - 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K801388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1980
Decision Date July 28, 1980
Days to Decision 45 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
77d faster than avg
Panel avg: 122d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIH Dispenser, Cement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4200
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 - KIH Dispenser, Cement

All 9
Devices cleared under the same product code (KIH) and FDA review panel - the closest regulatory comparables to K801388.
ORTHOPEADIC CEMENT DELIVERY SYSTEM
K851881 · Dentsply Intl. · Jun 1985
BRIGHAM TIBIAL CEMENT PRESSURIZER
K833675 · Howmedica Corp. · Dec 1983
HOWMEDICA FEMORAL PRESSURING SEAL
K811317 · Howmedica Corp. · May 1981
GUN, EXETER CEMENT
K790275 · Howmedica Corp. · Feb 1979
GUN, CEMENT
K781955 · Depuy, Inc. · Dec 1978
BONE CEMENT APPLICATOR
K780266 · Zimmer, Inc. · Feb 1978