ERA · Otoscope
Ear, Nose, Throat · 21 CFR 874.4770 · Class 1
Overview
| Product Code | ERA |
|---|---|
| Device Name | Otoscope |
| Regulation | 21 CFR 874.4770 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
Identification
An otoscope is a device intended to allow inspection of the external ear canal and tympanic membrane under magnification. The device provides illumination of the ear canal for observation by using an AC- or battery-powered light source and an optical magnifying system.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9 only when used in the external ear canal.
Recent Cleared Devices (20 of 56)
Showing 20 most recent of 56 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K123821 | AIO HD OTOSCOPE | Blue Focus | May 17, 2013 | SESE |
| K121326 | LANTOS 3D EAR SCANNER | Lantos Technologies | Jan 25, 2013 | SESE |
| K110326 | OSRAM ITOS | Osram Sylvania, Inc. | Oct 27, 2011 | SESE |
| K945264 | OPTUS OTOSCOPES | Optus, Inc. | Feb 2, 1996 | SESE |
| K955043 | WELCH ALLYN BI-OTOSCOPE | Welch Allyn, Inc. | Nov 14, 1995 | SESE |
| K952578 | WELCH ALLY OTOSCOPE | Welch Allyn, Inc. | Jul 10, 1995 | SESE |
| K950913 | PERFECT, ENT SET, PRAKTIKANT, DE LUXE | Rudolf Riester GmbH & Co. KG | May 12, 1995 | SESE |
| K950788 | OTOSCOPE A-34 | Neitz Instruments Company, Ltd. | May 3, 1995 | SESE |
| K951050 | SPECULUM, ENT (S3) | Pedia Pals, Inc. | Apr 17, 1995 | SESE |
| K951049 | SPECULUM, ENT (S3) | Pedia Pals, Inc. | Apr 17, 1995 | SESE |
| K951255 | IMEDGE VIDEO OSTOSCOPE (ANALOG) | Introspect, Inc. | Apr 13, 1995 | SESE |
| K950983 | IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE | Introspect, Inc. | Apr 12, 1995 | SESE |
| K950787 | WELCH ALLYN OTOSCOPE | Welch Allyn, Inc. | Apr 6, 1995 | SESE |
| K946043 | H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG | Rudolf Riester GmbH & Co. KG | Mar 8, 1995 | SESK |
| K943721 | OTOVIEW TELESCOPIC OTOSCOPES | Smith & Nephew, Inc. | Nov 18, 1994 | SESE |
| K944897 | HOME CARE EAR EXAMINATIO KIT | Home Care Instruments, Inc. | Nov 8, 1994 | SESE |
| K943731 | VIDEO OTOSCOPE | Cuda Products Co. | Oct 11, 1994 | SESE |
| K944031 | VIDEO SCOPE SYSTEM (OTOSCOPE) | Jedmed Instrument Co. | Sep 23, 1994 | SESE |
| K943916 | VIDEOTOSCOPE | Welch Allyn, Inc. | Aug 25, 1994 | SESE |
| K942244 | REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE | National Custom Ent., Inc. | Jun 24, 1994 | SESE |
Top Applicants
- Welch Allyn, Inc. — 9 clearances
- Rudolf Riester GmbH & Co. KG — 9 clearances
- Jedmed Instrument Co. — 4 clearances
- Pedia Pals, Inc. — 3 clearances
- Oticon Corp. — 2 clearances
