Cleared Traditional

K832540 - DRUMTO STAPES PROSTHESIS

K832540 is an FDA 510(k) clearance for DRUMTO STAPES PROSTHESIS, manufactured by Humboldt Products. The device is a Class 2 Ear, Nose, Throat device with product code ETB cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K832540 · Humboldt Products · Ear, Nose, Throat device
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Jan 1984
Decision
158d
Days
Class 2
Risk

K832540 is an FDA 510(k) clearance for the DRUMTO STAPES PROSTHESIS. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Humboldt Products (Walker, US). The FDA issued a Cleared decision on January 3, 1984 after a review of 158 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Humboldt Products devices

FDA 510(k) Submission Details - K832540

510(k) Number K832540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1983
Decision Date January 03, 1984
Days to Decision 158 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 89d · This submission: 158d
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 K832540.
INCUS/STAPES PROSTHESIS
K861369 · Richards Medical Co., Inc. · Jul 1986
INCUS PROSTHESIS
K844961 · Richards Medical Co., Inc. · Feb 1985
CAUSSE SPONGE BOAT
K841353 · Treace Medical, Inc. · Jul 1984
FISCH MODIFIED TEF-WIRE PISTON
K823429 · Treace Medical, Inc. · Dec 1982
CAUSSE TEF-PISTON
K823439 · Treace Medical, Inc. · Dec 1982
MCGEE MODIFIED STAINLESS STEEL PISTON
K823440 · Treace Medical, Inc. · Dec 1982