Cleared Traditional

PASCAL MEDICAL AB MENIETT 20 (K991562) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K991562 · Pascal Medical AB · Ear, Nose, Throat device
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Dec 1999
Decision
238d
Days
Class 2
Risk

K991562 is an FDA 510(k) clearance for the PASCAL MEDICAL AB MENIETT 20. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Pascal Medical AB (Minneapolis, US). The FDA issued a Cleared decision on December 28, 1999 after a review of 238 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1090 - 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 Pascal Medical AB devices

Submission Details

510(k) Number K991562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1999
Decision Date December 28, 1999
Days to Decision 238 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
149d slower than avg
Panel avg: 89d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ETY Tester, Auditory Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1090
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.