Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart E — Surgical Devices](/submissions/EN/subpart-e%E2%80%94surgical-devices) → [21 CFR 874.4770](/submissions/EN/subpart-e%E2%80%94surgical-devices/874.4770) → ERA — Otoscope # ERA · Otoscope _Ear, Nose, Throat · 21 CFR 874.4770 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA ## Overview - **Product Code:** ERA - **Device Name:** Otoscope - **Regulation:** [21 CFR 874.4770](/submissions/EN/subpart-e%E2%80%94surgical-devices/874.4770) - **Device Class:** 1 - **Review Panel:** [Ear, Nose, Throat](/submissions/EN) ## 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](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K123821.md) | AIO HD OTOSCOPE | Blue Focus | May 17, 2013 | SESE | | [K121326](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K121326.md) | LANTOS 3D EAR SCANNER | Lantos Technologies | Jan 25, 2013 | SESE | | [K110326](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K110326.md) | OSRAM ITOS | Osram Sylvania, Inc. | Oct 27, 2011 | SESE | | [K945264](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K945264.md) | OPTUS OTOSCOPES | Optus, Inc. | Feb 2, 1996 | SESE | | [K955043](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K955043.md) | WELCH ALLYN BI-OTOSCOPE | Welch Allyn, Inc. | Nov 14, 1995 | SESE | | [K952578](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K952578.md) | WELCH ALLY OTOSCOPE | Welch Allyn, Inc. | Jul 10, 1995 | SESE | | [K950913](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K950913.md) | PERFECT, ENT SET, PRAKTIKANT, DE LUXE | Rudolf Riester GmbH & Co. KG | May 12, 1995 | SESE | | [K950788](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K950788.md) | OTOSCOPE A-34 | Neitz Instruments Company, Ltd. | May 3, 1995 | SESE | | [K951050](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K951050.md) | SPECULUM, ENT (S3) | Pedia Pals, Inc. | Apr 17, 1995 | SESE | | [K951049](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K951049.md) | SPECULUM, ENT (S3) | Pedia Pals, Inc. | Apr 17, 1995 | SESE | | [K951255](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K951255.md) | IMEDGE VIDEO OSTOSCOPE (ANALOG) | Introspect, Inc. | Apr 13, 1995 | SESE | | [K950983](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K950983.md) | IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE | Introspect, Inc. | Apr 12, 1995 | SESE | | [K950787](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K950787.md) | WELCH ALLYN OTOSCOPE | Welch Allyn, Inc. | Apr 6, 1995 | SESE | | [K946043](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K946043.md) | H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG | Rudolf Riester GmbH & Co. KG | Mar 8, 1995 | SESK | | [K943721](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K943721.md) | OTOVIEW TELESCOPIC OTOSCOPES | Smith & Nephew, Inc. | Nov 18, 1994 | SESE | | [K944897](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K944897.md) | HOME CARE EAR EXAMINATIO KIT | Home Care Instruments, Inc. | Nov 8, 1994 | SESE | | [K943731](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K943731.md) | VIDEO OTOSCOPE | Cuda Products Co. | Oct 11, 1994 | SESE | | [K944031](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K944031.md) | VIDEO SCOPE SYSTEM (OTOSCOPE) | Jedmed Instrument Co. | Sep 23, 1994 | SESE | | [K943916](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K943916.md) | VIDEOTOSCOPE | Welch Allyn, Inc. | Aug 25, 1994 | SESE | | [K942244](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K942244.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com