Cleared Traditional

K955613 - MISTEN MEDICAL PARTIAL OSSICULAR REPLAC...

K955613 is an FDA 510(k) clearance for MISTEN MEDICAL PARTIAL OSSICULAR REPLAC..., manufactured by Misten Medical Corp.. The device is a Class 2 Ear, Nose, Throat device with product code ETB cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K955613 · Misten Medical Corp. · Ear, Nose, Throat device
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Dec 1995
Decision
11d
Days
Class 2
Risk

K955613 is an FDA 510(k) clearance for the MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), 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 874.3450 - 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 Misten Medical Corp. devices

FDA 510(k) Submission Details - K955613

510(k) Number K955613 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.

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.

Regulatory Peers - ETB Prosthesis, Partial Ossicular Replacement

All 37
Devices cleared under the same product code (ETB) and FDA review panel - the closest regulatory comparables to K955613.
MILLS INCUS HA SLEEVE
K974365 · Exmoor Plastics , Ltd. · Jan 1998
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS
K964909 · Xomed, Inc. · Mar 1997
RICHARDS TOTAL/PARTIAL PROSTHESIS
K962564 · Gyrus Ent LLC · Jan 1997
RICHARDS PORP
K952481 · Smith & Nephew Richards, Inc. · Jun 1995
HAPEX MALLEABLE PORP
K950885 · Smith & Nephew Richards, Inc. · Mar 1995
HAPEX PORP
K950886 · Smith & Nephew Richards, Inc. · Mar 1995