Otoscope
FDA product code ERA · Class I (low risk) · 21 CFR 874.4770 · Ear, Nose, Throat
56510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Rudolf Riester GmbH & Co. KG 9
- Welch Allyn, Inc. 9
- Jedmed Instrument Co. 4
- Pedia Pals, Inc. 3
- Introspect, Inc. 2
- Conphar, Inc. 2
- Artiberia 2
- Oticon Corp. 2
- Truphatek, Ltd. 1
- Blue Focus 1
- Xomed-Treace, Inc. 1
- Ear Care of So. Ca., Inc. 1
- Starkey Laboratories, Inc. 1
- Nankivell Industries, Inc. 1
- Earbear Co. 1
- Panex Corp. 1
- North American Medical Products, Inc. 1
- Plasti-Products, Inc. 1
- Terayco Intl., Ltd. 1
- Precision Professional Products 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123821 | Aio HD OtoscopeERA · Traditional | Blue Focus | 05/17/2013SE |
| K121326 | Lantos 3D Ear ScannerERA · Traditional | Lantos Technologies | 01/25/2013SE |
| K110326 | Osram ItosERA · Traditional | Osram Sylvania, Inc. | 10/27/2011SE |
| K945264 | Optus OtoscopesERA · Traditional | Optus, Inc. | 02/02/1996SE |
| K955043 | Welch Allyn Bi-OtoscopeERA · Traditional | Welch Allyn, Inc. | 11/14/1995SE |
| K952578 | Welch Ally OtoscopeERA · Traditional | Welch Allyn, Inc. | 07/10/1995SE |
| K950913 | Perfect, ENT Set, Praktikant, de LuxeERA · Traditional | Rudolf Riester GmbH & Co. KG | 05/12/1995SE |
| K950788 | Otoscope A-34ERA · Traditional | Neitz Instruments Company, Ltd. | 05/03/1995SE |
| K951050 | Speculum, ENT (S3)ERA · Traditional | Pedia Pals, Inc. | 04/17/1995SE |
| K951049 | Speculum, ENT (S3)ERA · Traditional | Pedia Pals, Inc. | 04/17/1995SE |
| K951255 | Imedge Video Ostoscope (Analog)ERA · Traditional | Introspect, Inc. | 04/13/1995SE |
| K950983 | Imedge Digita Otoscope or Digital Video OtoscopeERA · Traditional | Introspect, Inc. | 04/12/1995SE |
| K950787 | Welch Allyn OtoscopeERA · Traditional | Welch Allyn, Inc. | 04/06/1995SE |
| K946043 | H5000, H5000L, H5000L Reverse Model H5000C, H5000CGERA · Traditional | Rudolf Riester GmbH & Co. KG | 03/08/1995SESK |
| K943721 | Otoview Telescopic OtoscopesERA · Traditional | Smith & Nephew, Inc. | 11/18/1994SE |
| K944897 | Home Care Ear Examinatio KitERA · Traditional | Home Care Instruments, Inc. | 11/08/1994SE |
| K943731 | Video OtoscopeERA · Traditional | Cuda Products Co. | 10/11/1994SE |
| K944031 | Video Scope System (Otoscope)ERA · Traditional | Jedmed Instrument Co. | 09/23/1994SE |
| K943916 | VideotoscopeERA · Traditional | Welch Allyn, Inc. | 08/25/1994SE |
| K942244 | Replacement Batteries/Welch Allyn #72200 Power HandleERA · Traditional | National Custom Ent., Inc. | 06/24/1994SE |
| K941659 | Aural-Cam, Video Ear, Vid RXERA · Traditional | Gracefully Yours, Inc. | 04/26/1994SE |
| K932259 | Clarus Model 2240 Semi-Rigid OtoscopeERA · Traditional | Clarus Medical Systems, Inc. | 12/15/1993SE |
| K932506 | Ri-Scope (S)ERA · Traditional | Rudolf Riester GmbH & Co. KG | 10/08/1993SE |
| K932505 | Ri-StarERA · Traditional | Rudolf Riester GmbH & Co. KG | 10/08/1993SE |
| K932503 | Ri-MiniERA · Traditional | Rudolf Riester GmbH & Co. KG | 10/08/1993SE |
| K925753 | Uni IIIERA · Traditional | Rudolf Riester GmbH & Co. KG | 10/08/1993SE |
| K925752 | StandardERA · Traditional | Rudolf Riester GmbH & Co. KG | 10/08/1993SE |
| K925758 | OtoscopeERA · Traditional | Rudolf Riester GmbH & Co. KG | 08/03/1993SE |
| K925759 | Uni IERA · Traditional | Rudolf Riester GmbH & Co. KG | 07/26/1993SE |
| K923830 | Xomed-Treace AlphascopeERA · Traditional | Xomed-Treace, Inc. | 11/09/1992SE |
| K924025 | Oto-Brite HandleERA · Traditional | Jedmed Instrument Co. | 11/06/1992SE |
| K923304 | Family Ear Scope Model 29001SERA · Traditional | Ear Care of So. Ca., Inc. | 10/21/1992SE |
| K922752 | Starkey Laboratories OtoscopeERA · Traditional | Starkey Laboratories, Inc. | 09/04/1992SE |
| K920322 | OptiearERA · Traditional | Nankivell Industries, Inc. | 04/23/1992SE |
| K915537 | Earbear OtoscopeERA · Traditional | Earbear Co. | 01/24/1992SE |
| K911650 | Pedia PalsERA · Traditional | Pedia Pals, Inc. | 10/17/1991SE |
| K904659 | Dr. Dedo's Family Ear Examination KitERA · Traditional | Panex Corp. | 04/30/1991SE |
| K904802 | Video OtoscopeERA · Traditional | Jedmed Instrument Co. | 01/22/1991SE |
| K902205 | OtoscopeERA · Traditional | Truphatek, Ltd. | 08/14/1990SE |
| K896274 | TympanoscopeERA · Traditional | Jedmed Instrument Co. | 01/26/1990SE |
| K862661 | D.L. Scope(R) OtoscopeERA · Traditional | North American Medical Products, Inc. | 08/08/1986SE |
| K862624 | I81 CiteERA · Traditional | Oticon Corp. | 08/01/1986SE |
| K862621 | I22 InitialesERA · Traditional | Oticon Corp. | 08/01/1986SE |
| K851745 | 1-100 Universal Set Otoscope & Larynx Exploraton BERA · Traditional | Artiberia | 08/29/1985SE |
| K851746 | 1-110 Otoscope Set Battery Powered Diag. Set 3PCS.ERA · Traditional | Artiberia | 05/29/1985SE |
| K840593 | Disposa-SpecERA · Traditional | Plasti-Products, Inc. | 07/13/1984SE |
| K831614 | InspetoscopeERA · Traditional | Terayco Intl., Ltd. | 08/12/1983SE |
| K831709 | Audioscope #23000 W/71123 Charging StandERA · Traditional | Welch Allyn, Inc. | 06/30/1983SE |
| K813305 | Conphar OtoscopeERA · Traditional | Conphar, Inc. | 01/19/1982SE |
| K813299 | Conphar Otoscope/OpthalmascopeERA · Traditional | Conphar, Inc. | 01/19/1982SE |
| K813003 | P.P.P. Treatment CabinetERA · Traditional | Precision Professional Products | 11/06/1981SE |
| K800365 | EarscopeERA · Traditional | Nash & Assoc. | 03/10/1980SE |
| K782142 | Illiminator, Model 265 NasalERA · Traditional | Welch Allyn, Inc. | 01/26/1979SE |
| K781029 | Otoscope, Diag. Models 20100 & 20200ERA · Traditional | Welch Allyn, Inc. | 06/28/1978SE |
| K770770 | Wall Charger, Model #79111ERA · Traditional | Welch Allyn, Inc. | 04/29/1977SE |
| K770769 | Otoscope/Illuminator, Model #21100ERA · Traditional | Welch Allyn, Inc. | 04/29/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1962-2025 Class II | 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles…The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential… | Baxter Healthcare Corporation | 05/09/2025Open, Classified |