Cleared Traditional

K950886 - HAPEX PORP (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K950886 · Smith & Nephew Richards, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
15d
Days
Class 2
Risk

K950886 is an FDA 510(k) clearance for the HAPEX PORP. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Bartlett, US). The FDA issued a Cleared decision on March 15, 1995 after a review of 15 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 Smith & Nephew Richards, Inc. devices

Submission Details

510(k) Number K950886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1995
Decision Date March 15, 1995
Days to Decision 15 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 89d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

Regulatory Peers - ETB Prosthesis, Partial Ossicular Replacement

All 73
Devices cleared under the same product code (ETB) and FDA review panel - the closest regulatory comparables to K950886.
mGRIP Partial Prosthesis (0.75 mm) (58669)
K260718 · Med-El Elektromedizinische Ger?te GmbH · Apr 2026
mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717)
K260720 · Med-El Elektromedizinische Ger?te GmbH · Apr 2026
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
K241142 · Med-El Elektromedizinische Ger?te GmbH · Jan 2025
mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit
K241261 · Med-El Elektromedizinische Ger?te GmbH · Jan 2025