Cleared Traditional

K955615 - MISTEN MEDICAL TOTAL OSSICULAR REPLACEM...

K955615 is an FDA 510(k) clearance for MISTEN MEDICAL TOTAL OSSICULAR REPLACEM..., manufactured by Misten Medical Corp.. The device is a Class 2 Ear, Nose, Throat device with product code ETA cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K955615 · Misten Medical Corp. · Ear, Nose, Throat device
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Dec 1995
Decision
11d
Days
Class 2
Risk

K955615 is an FDA 510(k) clearance for the MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS. Classified as Replacement, Ossicular Prosthesis, Total (product code ETA), Class II - Special Controls.

Submitted by Misten Medical Corp. (Germantown, US). The FDA issued a Cleared decision on December 22, 1995 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3495 - 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 Misten Medical Corp. devices

FDA 510(k) Submission Details - K955615

510(k) Number K955615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1995
Decision Date December 22, 1995
Days to Decision 11 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 89d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETA Device Classification - Class 2, Special Controls

Product Code ETA Replacement, Ossicular Prosthesis, Total
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3495
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 - ETA Replacement, Ossicular Prosthesis, Total

All 21
Devices cleared under the same product code (ETA) and FDA review panel - the closest regulatory comparables to K955615.
BOJRAB MICRO-TORP, MODEL 7014-5845
K990601 · Gyrus Ent LLC · Mar 1999
MILLS COLUMELLA PROSTHESIS
K981088 · Exmoor Plastics , Ltd. · Jun 1998
CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)
K963899 · Exmoor Plastics , Ltd. · Aug 1997
RICHARDS TORP
K952549 · Smith & Nephew Richards, Inc. · Jul 1995
HAPEX MALLEABLE TORP
K950927 · Smith & Nephew Richards, Inc. · Mar 1995
BLACK OVAL-TOP TORP/PORP
K934107 · Smith & Nephew Richards, Inc. · Jun 1994