Cleared Traditional

MINIMUFFS (K935160) - FDA 510(k) Clearance

K935160 · Natus Medical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
468d
Days
-
Risk

K935160 is an FDA 510(k) clearance for the MINIMUFFS. Classified as Protector, Hearing (circumaural) (product code EWE).

Submitted by Natus Medical, Inc. (San Carlos, US). The FDA issued a Cleared decision on February 9, 1995 after a review of 468 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Natus Medical, Inc. devices

Submission Details

510(k) Number K935160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1993
Decision Date February 09, 1995
Days to Decision 468 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
379d slower than avg
Panel avg: 89d · This submission: 468d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EWE Protector, Hearing (circumaural)
Device Class -