Product Code: ERA FDA class 1 21 CFR 874.4770

Otoscope

Ear, Nose, Throat

The otoscope is a handheld diagnostic instrument equipped with a light source and magnifying lens used to visually examine the external ear canal and tympanic membrane for signs of infection, blockage, or other pathology. It is classified as FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. The product code is ERA, regulated under 21 CFR 874.4770 in the Ear, Nose, Throat specialty. No special regulatory flags apply.

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510(k)s

FEI Numbers

228

Registration Numbers

228

Unique Applicants

Years Active

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Basic Information

Product Code: ERA
Device Class: FDA class 1
Regulation Number: 874.4770
Medical Specialty: Ear, Nose, Throat
Review Panel: EN
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 56 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K123821	AIO HD OTOSCOPE	May 17, 2013	Substantially Equivalent	Blue Focus
K121326	LANTOS 3D EAR SCANNER	Jan 25, 2013	Substantially Equivalent	Lantos Technologies
K110326	OSRAM ITOS	Oct 27, 2011	Substantially Equivalent	Osram Sylvania, Inc.
K945264	OPTUS OTOSCOPES	Feb 02, 1996	Substantially Equivalent	Optus, Inc.
K955043	WELCH ALLYN BI-OTOSCOPE	Nov 14, 1995	Substantially Equivalent	Welch Allyn, Inc.
K952578	WELCH ALLY OTOSCOPE	Jul 10, 1995	Substantially Equivalent	Welch Allyn, Inc.
K950913	PERFECT, ENT SET, PRAKTIKANT, DE LUXE	May 12, 1995	Substantially Equivalent	Rudolf Riester GmbH & Co. KG
K950788	OTOSCOPE A-34	May 03, 1995	Substantially Equivalent	Neitz Instruments Company, Ltd.
K951050	SPECULUM, ENT (S3)	Apr 17, 1995	Substantially Equivalent	Pedia Pals, Inc.
K951049	SPECULUM, ENT (S3)	Apr 17, 1995	Substantially Equivalent	Pedia Pals, Inc.
K951255	IMEDGE VIDEO OSTOSCOPE (ANALOG)	Apr 13, 1995	Substantially Equivalent	Introspect, Inc.
K950983	IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE	Apr 12, 1995	Substantially Equivalent	Introspect, Inc.
K950787	WELCH ALLYN OTOSCOPE	Apr 06, 1995	Substantially Equivalent	Welch Allyn, Inc.
K946043	H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG	Mar 08, 1995	Unknown	Rudolf Riester GmbH & Co. KG
K943721	OTOVIEW TELESCOPIC OTOSCOPES	Nov 18, 1994	Substantially Equivalent	Smith & Nephew, Inc.
K944897	HOME CARE EAR EXAMINATIO KIT	Nov 08, 1994	Substantially Equivalent	Home Care Instruments, Inc.
K943731	VIDEO OTOSCOPE	Oct 11, 1994	Substantially Equivalent	Cuda Products Co.
K944031	VIDEO SCOPE SYSTEM (OTOSCOPE)	Sep 23, 1994	Substantially Equivalent	Jedmed Instrument Co.
K943916	VIDEOTOSCOPE	Aug 25, 1994	Substantially Equivalent	Welch Allyn, Inc.
K942244	REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE	Jun 24, 1994	Substantially Equivalent	National Custom Ent., Inc.
K941659	AURAL-CAM, VIDEO EAR, VID RX	Apr 26, 1994	Substantially Equivalent	Gracefully Yours, Inc.
K932259	CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE	Dec 15, 1993	Substantially Equivalent	Clarus Medical Systems, Inc.
K932506	RI-SCOPE (S)	Oct 08, 1993	Substantially Equivalent	Rudolf Riester GmbH & Co. KG
K932505	RI-STAR	Oct 08, 1993	Substantially Equivalent	Rudolf Riester GmbH & Co. KG
K932503	RI-MINI	Oct 08, 1993	Substantially Equivalent	Rudolf Riester GmbH & Co. KG
K925753	UNI III	Oct 08, 1993	Substantially Equivalent	Rudolf Riester GmbH & Co. KG
K925752	STANDARD	Oct 08, 1993	Substantially Equivalent	Rudolf Riester GmbH & Co. KG
K925758	OTOSCOPE	Aug 03, 1993	Substantially Equivalent	Rudolf Riester GmbH & Co. KG
K925759	UNI I	Jul 26, 1993	Substantially Equivalent	Rudolf Riester GmbH & Co. KG
K923830	XOMED-TREACE ALPHASCOPE	Nov 09, 1992	Substantially Equivalent	Xomed-Treace, Inc.
K924025	OTO-BRITE HANDLE	Nov 06, 1992	Substantially Equivalent	Jedmed Instrument Co.
K923304	FAMILY EAR SCOPE MODEL 29001S	Oct 21, 1992	Substantially Equivalent	Ear Care of So. Ca., Inc.
K922752	STARKEY LABORATORIES OTOSCOPE	Sep 04, 1992	Substantially Equivalent	Starkey Laboratories, Inc.
K920322	OPTIEAR	Apr 23, 1992	Substantially Equivalent	Nankivell Industries, Inc.
K915537	EARBEAR OTOSCOPE	Jan 24, 1992	Substantially Equivalent	Earbear Co.
K911650	PEDIA PALS	Oct 17, 1991	Substantially Equivalent	Pedia Pals, Inc.
K904659	DR. DEDO'S FAMILY EAR EXAMINATION KIT	Apr 30, 1991	Substantially Equivalent	Panex Corp.
K904802	VIDEO OTOSCOPE	Jan 22, 1991	Substantially Equivalent	Jedmed Instrument Co.
K902205	OTOSCOPE	Aug 14, 1990	Substantially Equivalent	Truphatek, Ltd.
K896274	TYMPANOSCOPE	Jan 26, 1990	Substantially Equivalent	Jedmed Instrument Co.
K862661	D.L. SCOPE(R) OTOSCOPE	Aug 08, 1986	Substantially Equivalent	North American Medical Products, Inc.
K862624	I81 CITE	Aug 01, 1986	Substantially Equivalent	Oticon Corp.
K862621	I22 INITIALES	Aug 01, 1986	Substantially Equivalent	Oticon Corp.
K851745	1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B	Aug 29, 1985	Substantially Equivalent	Artiberia
K851746	1-110 OTOSCOPE SET BATTERY POWERED DIAG. SET 3PCS.	May 29, 1985	Substantially Equivalent	Artiberia
K840593	DISPOSA-SPEC	Jul 13, 1984	Substantially Equivalent	Plasti-Products, Inc.
K831614	INSPETOSCOPE	Aug 12, 1983	Substantially Equivalent	Terayco Intl., Ltd.
K831709	AUDIOSCOPE #23000 W/71123 CHARGING STAND	Jun 30, 1983	Substantially Equivalent	Welch Allyn, Inc.
K813305	CONPHAR OTOSCOPE	Jan 19, 1982	Substantially Equivalent	Conphar, Inc.
K813299	CONPHAR OTOSCOPE/OPTHALMASCOPE	Jan 19, 1982	Substantially Equivalent	Conphar, Inc.
K813003	P.P.P. TREATMENT CABINET	Nov 06, 1981	Substantially Equivalent	Precision Professional Products
K800365	EARSCOPE	Mar 10, 1980	Substantially Equivalent	Nash & Assoc.
K782142	ILLIMINATOR, MODEL 265 NASAL	Jan 26, 1979	Substantially Equivalent	Welch Allyn, Inc.
K781029	OTOSCOPE, DIAG. MODELS 20100 & 20200	Jun 28, 1978	Substantially Equivalent	Welch Allyn, Inc.
K770770	WALL CHARGER, MODEL #79111	Apr 29, 1977	Substantially Equivalent	Welch Allyn, Inc.
K770769	OTOSCOPE/ILLUMINATOR, MODEL #21100	Apr 29, 1977	Substantially Equivalent	Welch Allyn, Inc.