Cleared Traditional

K920840 - OTOVENT (FDA 510(k) Clearance)

K920840 · Abigo Medical AB · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Oct 1992
Decision
224d
Days
-
Risk

K920840 is an FDA 510(k) clearance for the OTOVENT. Classified as Device, Inflation, Middle Ear within the MJV classification (a niche ENT category for middle ear pressure regulation devices).

Submitted by Abigo Medical AB (Sweden, SE). The FDA issued a Cleared decision on October 5, 1992 after a review of 224 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel. 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. Middle ear inflation devices represent a low-volume ENT category with limited predicate history - the 165-day review reflects the FDA's careful equivalence assessment for this specialized device type.

View all Abigo Medical AB devices

Submission Details

510(k) Number K920840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1992
Decision Date October 05, 1992
Days to Decision 224 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 89d · This submission: 224d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MJV Device, Inflation, Middle Ear
Device Class -