Cleared Traditional

K913619 - CERAVITAL MIDDLE EAR IMPLANT

K913619 is an FDA 510(k) clearance for CERAVITAL MIDDLE EAR IMPLANT, manufactured by Friedrichsfeld Medizintechnik AG. The device is a Class 2 Ear, Nose, Throat device with product code ETB cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K913619 · Friedrichsfeld Medizintechnik AG · Ear, Nose, Throat device
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Oct 1991
Decision
63d
Days
Class 2
Risk

K913619 is an FDA 510(k) clearance for the CERAVITAL MIDDLE EAR IMPLANT. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Friedrichsfeld Medizintechnik AG (Walnut Creek, US). The FDA issued a Cleared decision on October 15, 1991 after a review of 63 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 Friedrichsfeld Medizintechnik AG devices

FDA 510(k) Submission Details - K913619

510(k) Number K913619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1991
Decision Date October 15, 1991
Days to Decision 63 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
26d faster than avg
Panel avg: 89d · This submission: 63d
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 K913619.
HAPES MALLEABLE INCUS STAPES
K950984 · Smith & Nephew Richards, Inc. · Mar 1995
INCUDOSTAPEDIAL JOINT
K925443 · Smith & Nephew Richards, Inc. · Mar 1993
WEHRS INCUS AND INCUS-STAPES PROSTHESES
K910685 · Smith & Nephew Richards, Inc. · Dec 1991
BUCKET PROSTHESIS PORP
K883727 · Treace Medical, Inc. · Jan 1989
XOMED PLATINUM WIRE TEFLON PISTION
K872112 · Xomed, Inc. · Jul 1987
PROSTHESIS WIRE
K870766 · Treace Medical, Inc. · Apr 1987