Atlas FDA

ERA

56 FDA 510(k) clearances · Product code

85 daysmedian time to decision
263 days90th percentile
56clearances measured

FDA profile

Official device name
Otoscope
Device class
Class I (low risk)
Regulation
21 CFR 874.4770
Medical specialty
Ear, Nose, Throat
Adverse events (MAUDE)
1994: 1 · 1997: 1 · 2002: 1 · 2003: 1 · 2004: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
AIO HD OTOSCOPE (K123821)Blue Focus2013-05-17
LANTOS 3D EAR SCANNER (K121326)Lantos Technologies2013-01-25
OSRAM ITOS (K110326)Osram Sylvania, Inc.2011-10-27
OPTUS OTOSCOPES (K945264)Optus, Inc.1996-02-02
WELCH ALLYN BI-OTOSCOPE (K955043)Welch Allyn, Inc.1995-11-14
WELCH ALLY OTOSCOPE (K952578)Welch Allyn, Inc.1995-07-10
PERFECT, ENT SET, PRAKTIKANT, DE LUXE (K950913)Rudolf Riester GmbH & Co. KG1995-05-12
OTOSCOPE A-34 (K950788)Neitz Instruments Company, Ltd.1995-05-03
SPECULUM, ENT (S3) (K951050)Pedia Pals, Inc.1995-04-17
SPECULUM, ENT (S3) (K951049)Pedia Pals, Inc.1995-04-17
IMEDGE VIDEO OSTOSCOPE (ANALOG) (K951255)Introspect, Inc.1995-04-13
IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE (K950983)Introspect, Inc.1995-04-12
WELCH ALLYN OTOSCOPE (K950787)Welch Allyn, Inc.1995-04-06
H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG (K946043)Rudolf Riester GmbH & Co. KG1995-03-08
OTOVIEW TELESCOPIC OTOSCOPES (K943721)Smith & Nephew, Inc.1994-11-18
HOME CARE EAR EXAMINATIO KIT (K944897)Home Care Instruments, Inc.1994-11-08
VIDEO OTOSCOPE (K943731)Cuda Products Co.1994-10-11
VIDEO SCOPE SYSTEM (OTOSCOPE) (K944031)Jedmed Instrument Co.1994-09-23
VIDEOTOSCOPE (K943916)Welch Allyn, Inc.1994-08-25
REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE (K942244)National Custom Ent., Inc.1994-06-24
AURAL-CAM, VIDEO EAR, VID RX (K941659)Gracefully Yours, Inc.1994-04-26
CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE (K932259)Clarus Medical Systems, Inc.1993-12-15
RI-SCOPE (S) (K932506)Rudolf Riester GmbH & Co. KG1993-10-08
UNI III (K925753)Rudolf Riester GmbH & Co. KG1993-10-08
RI-MINI (K932503)Rudolf Riester GmbH & Co. KG1993-10-08
RI-STAR (K932505)Rudolf Riester GmbH & Co. KG1993-10-08
STANDARD (K925752)Rudolf Riester GmbH & Co. KG1993-10-08
OTOSCOPE (K925758)Rudolf Riester GmbH & Co. KG1993-08-03
UNI I (K925759)Rudolf Riester GmbH & Co. KG1993-07-26
XOMED-TREACE ALPHASCOPE (K923830)Xomed-Treace, Inc.1992-11-09
OTO-BRITE HANDLE (K924025)Jedmed Instrument Co.1992-11-06
FAMILY EAR SCOPE MODEL 29001S (K923304)Ear Care of So. Ca., Inc.1992-10-21
STARKEY LABORATORIES OTOSCOPE (K922752)Starkey Laboratories, Inc.1992-09-04
OPTIEAR (K920322)Nankivell Industries, Inc.1992-04-23
EARBEAR OTOSCOPE (K915537)Earbear Co.1992-01-24
PEDIA PALS (K911650)Pedia Pals, Inc.1991-10-17
DR. DEDO'S FAMILY EAR EXAMINATION KIT (K904659)Panex Corp.1991-04-30
VIDEO OTOSCOPE (K904802)Jedmed Instrument Co.1991-01-22
OTOSCOPE (K902205)Truphatek, Ltd.1990-08-14
TYMPANOSCOPE (K896274)Jedmed Instrument Co.1990-01-26
D.L. SCOPE(R) OTOSCOPE (K862661)North American Medical Products, Inc.1986-08-08
I22 INITIALES (K862621)Oticon Corp.1986-08-01
I81 CITE (K862624)Oticon Corp.1986-08-01
1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B (K851745)Artiberia1985-08-29
1-110 OTOSCOPE SET BATTERY POWERED DIAG. SET 3PCS. (K851746)Artiberia1985-05-29
DISPOSA-SPEC (K840593)Plasti-Products, Inc.1984-07-13
INSPETOSCOPE (K831614)Terayco Intl., Ltd.1983-08-12
AUDIOSCOPE #23000 W/71123 CHARGING STAND (K831709)Welch Allyn, Inc.1983-06-30
CONPHAR OTOSCOPE/OPTHALMASCOPE (K813299)Conphar, Inc.1982-01-19
CONPHAR OTOSCOPE (K813305)Conphar, Inc.1982-01-19
P.P.P. TREATMENT CABINET (K813003)Precision Professional Products1981-11-06
EARSCOPE (K800365)Nash & Assoc.1980-03-10
ILLIMINATOR, MODEL 265 NASAL (K782142)Welch Allyn, Inc.1979-01-26
OTOSCOPE, DIAG. MODELS 20100 & 20200 (K781029)Welch Allyn, Inc.1978-06-28
WALL CHARGER, MODEL #79111 (K770770)Welch Allyn, Inc.1977-04-29
OTOSCOPE/ILLUMINATOR, MODEL #21100 (K770769)Welch Allyn, Inc.1977-04-29

Track ERA automatically

Every clearance here is in the API, with alerts when new ones post.