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.
Cleared Devices (56)
| 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 |
| K941659 | AURAL-CAM, VIDEO EAR, VID RX | Gracefully Yours, Inc. | Apr 26, 1994 | SESE |
| K932259 | CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE | Clarus Medical Systems, Inc. | Dec 15, 1993 | SESE |
| K932506 | RI-SCOPE (S) | Rudolf Riester GmbH & Co. KG | Oct 8, 1993 | SESE |
| K932505 | RI-STAR | Rudolf Riester GmbH & Co. KG | Oct 8, 1993 | SESE |
| K932503 | RI-MINI | Rudolf Riester GmbH & Co. KG | Oct 8, 1993 | SESE |
| K925753 | UNI III | Rudolf Riester GmbH & Co. KG | Oct 8, 1993 | SESE |
| K925752 | STANDARD | Rudolf Riester GmbH & Co. KG | Oct 8, 1993 | SESE |
| K925758 | OTOSCOPE | Rudolf Riester GmbH & Co. KG | Aug 3, 1993 | SESE |
| K925759 | UNI I | Rudolf Riester GmbH & Co. KG | Jul 26, 1993 | SESE |
| K923830 | XOMED-TREACE ALPHASCOPE | Xomed-Treace, Inc. | Nov 9, 1992 | SESE |
| K924025 | OTO-BRITE HANDLE | Jedmed Instrument Co. | Nov 6, 1992 | SESE |
| K923304 | FAMILY EAR SCOPE MODEL 29001S | Ear Care of So. Ca., Inc. | Oct 21, 1992 | SESE |
| K922752 | STARKEY LABORATORIES OTOSCOPE | Starkey Laboratories, Inc. | Sep 4, 1992 | SESE |
| K920322 | OPTIEAR | Nankivell Industries, Inc. | Apr 23, 1992 | SESE |
| K915537 | EARBEAR OTOSCOPE | Earbear Co. | Jan 24, 1992 | SESE |
| K911650 | PEDIA PALS | Pedia Pals, Inc. | Oct 17, 1991 | SESE |
| K904659 | DR. DEDO'S FAMILY EAR EXAMINATION KIT | Panex Corp. | Apr 30, 1991 | SESE |
| K904802 | VIDEO OTOSCOPE | Jedmed Instrument Co. | Jan 22, 1991 | SESE |
| K902205 | OTOSCOPE | Truphatek, Ltd. | Aug 14, 1990 | SESE |
| K896274 | TYMPANOSCOPE | Jedmed Instrument Co. | Jan 26, 1990 | SESE |
| K862661 | D.L. SCOPE(R) OTOSCOPE | North American Medical Products, Inc. | Aug 8, 1986 | SESE |
| K862624 | I81 CITE | Oticon Corp. | Aug 1, 1986 | SESE |
| K862621 | I22 INITIALES | Oticon Corp. | Aug 1, 1986 | SESE |
| K851745 | 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B | Artiberia | Aug 29, 1985 | SESE |
| K851746 | 1-110 OTOSCOPE SET BATTERY POWERED DIAG. SET 3PCS. | Artiberia | May 29, 1985 | SESE |
| K840593 | DISPOSA-SPEC | Plasti-Products, Inc. | Jul 13, 1984 | SESE |
| K831614 | INSPETOSCOPE | Terayco Intl., Ltd. | Aug 12, 1983 | SESE |
| K831709 | AUDIOSCOPE #23000 W/71123 CHARGING STAND | Welch Allyn, Inc. | Jun 30, 1983 | SESE |
| K813305 | CONPHAR OTOSCOPE | Conphar, Inc. | Jan 19, 1982 | SESE |
| K813299 | CONPHAR OTOSCOPE/OPTHALMASCOPE | Conphar, Inc. | Jan 19, 1982 | SESE |
| K813003 | P.P.P. TREATMENT CABINET | Precision Professional Products | Nov 6, 1981 | SESE |
| K800365 | EARSCOPE | Nash & Assoc. | Mar 10, 1980 | SESE |
| K782142 | ILLIMINATOR, MODEL 265 NASAL | Welch Allyn, Inc. | Jan 26, 1979 | SESE |
| K781029 | OTOSCOPE, DIAG. MODELS 20100 & 20200 | Welch Allyn, Inc. | Jun 28, 1978 | SESE |
| K770770 | WALL CHARGER, MODEL #79111 | Welch Allyn, Inc. | Apr 29, 1977 | SESE |
| K770769 | OTOSCOPE/ILLUMINATOR, MODEL #21100 | Welch Allyn, Inc. | Apr 29, 1977 | 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
