510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
ERAClass I

Otoscope

21 CFR 874.4770 / Ear, Nose, Throat
FDA source (opens on fda.gov)

ERA is the FDA product code for Otoscope, a class I device type, regulated under 21 CFR 874.4770. As of , FDA records hold 56 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
ERA
Device name
Otoscope
Regulation
21 CFR 874.4770
Device class
Class I
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
56
Ingested recalls
1

Clearances, product code ERA

By decision year
56 clearances under product code ERA with a decision year between 1977 and 2013, 1995 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code ERA by decision year
YearClearances
19772
19781
19791
19801
19811
19822
19832
19841
19852
19863
19902
19913
19926
19938
19947
199510
19961
20111
20132

Applicants with the most clearances

Product code ERA
Applicants holding the most 510(k) clearances under product code ERA
ApplicantClearances
Rudolf Riester GmbH & Co. KG9
Welch Allyn Inc9
JEDMED Instrument Company4
Pedia Pals, Inc.3
Artiberia2
Conphar, Inc.2
Introspect, Inc.2
Oticon, Inc.2
Blue Focus1
Clarus Medical Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 227 companies shown, in name order