Cleared Traditional

K823483 - STAINLESS STEEL PISTONS

K823483 is an FDA 510(k) clearance for STAINLESS STEEL PISTONS, 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 16-day FDA review.

K823483 · Humboldt Products · Ear, Nose, Throat device
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Dec 1982
Decision
16d
Days
Class 2
Risk

K823483 is an FDA 510(k) clearance for the STAINLESS STEEL PISTONS. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Humboldt Products (Mchenry, US). The FDA issued a Cleared decision on December 9, 1982 after a review of 16 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 Humboldt Products devices

FDA 510(k) Submission Details - K823483

510(k) Number K823483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1982
Decision Date December 09, 1982
Days to Decision 16 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
73d faster than avg
Panel avg: 89d · This submission: 16d
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 K823483.
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