Cleared Traditional

K950788 - OTOSCOPE A-34

K950788 is an FDA 510(k) clearance for OTOSCOPE A-34, manufactured by Neitz Instruments Company, Ltd.. The device is a Class 1 Ear, Nose, Throat device with product code ERA cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K950788 · Neitz Instruments Company, Ltd. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
71d
Days
Class 1
Risk

K950788 is an FDA 510(k) clearance for the OTOSCOPE A-34. Classified as Otoscope (product code ERA), Class I - General Controls.

Submitted by Neitz Instruments Company, Ltd. (Tokyo, JP). The FDA issued a Cleared decision on May 3, 1995 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4770 - 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 Neitz Instruments Company, Ltd. devices

FDA 510(k) Submission Details - K950788

510(k) Number K950788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1995
Decision Date May 03, 1995
Days to Decision 71 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 89d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

ERA Device Classification - Class 1, General Controls

Product Code ERA Otoscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4770
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ERA Otoscope

All 30
Devices cleared under the same product code (ERA) and FDA review panel - the closest regulatory comparables to K950788.
WELCH ALLYN BI-OTOSCOPE
K955043 · Welch Allyn, Inc. · Nov 1995
WELCH ALLY OTOSCOPE
K952578 · Welch Allyn, Inc. · Jul 1995
PERFECT, ENT SET, PRAKTIKANT, DE LUXE
K950913 · Rudolf Riester GmbH & Co. KG · May 1995
WELCH ALLYN OTOSCOPE
K950787 · Welch Allyn, Inc. · Apr 1995
H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG
K946043 · Rudolf Riester GmbH & Co. KG · Mar 1995
OTOVIEW TELESCOPIC OTOSCOPES
K943721 · Smith & Nephew, Inc. · Nov 1994