510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955043Substantially Equivalent

Welch Allyn Bi-Otoscope

Welch Allyn Inc, Skaneateles Falls NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955043 is the FDA 510(k) clearance record for WELCH ALLYN BI-OTOSCOPE, a class I device, cleared for Welch Allyn, Inc. on under FDA product code ERA (Otoscope). FDA records list 112 510(k) clearances for Welch Allyn, Inc., from to . As of , FDA records show no recalls naming K955043.

Clearance record

Decision date
Received
(11 days to decision)
Product code
ERA Otoscope
Regulation
21 CFR 874.4770
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Welch Allyn, Inc. 4341 State St. Rd., Skaneateles Falls NY
510(k) summary
Summary
Third party review
No

Clearances, product code ERA

Trailing 12 months

FDA records hold no clearances under product code ERA in the trailing twelve months.

FDA records show no clearances under product code ERA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ERA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260