Cleared Traditional

K760435 - PISTON

K760435 is an FDA 510(k) clearance for PISTON, manufactured by Richard'S Medical Equip., Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETB cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K760435 · Richard'S Medical Equip., Inc. · Ear, Nose, Throat device
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Sep 1976
Decision
42d
Days
Class 2
Risk

K760435 is an FDA 510(k) clearance for the PISTON, PLATINUM TEFLON, OTOLOGY IMPLANT. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Richard'S Medical Equip., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1976 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3450 - the FDA ear, nose and throat 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 Richard'S Medical Equip., Inc. devices

FDA 510(k) Submission Details - K760435

510(k) Number K760435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1976
Decision Date September 27, 1976
Days to Decision 42 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 89d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETB Device Classification - Class 2, Special Controls

Product Code ETB Prosthesis, Partial Ossicular Replacement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.