510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203807Substantially Equivalent

Ponto Bone Anchored Hearing System, MONO Surgery Kit

Oticon Medical AB, Askim, SE / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203807 is the FDA 510(k) clearance record for Ponto Bone Anchored Hearing System, MONO Surgery Kit, a class II device, cleared for Oticon Medical AB on under FDA product code MAH (Hearing Aid, Bone Conduction, Implanted). FDA records list 16 510(k) clearances for Oticon Medical AB, from to . As of , FDA records show no recalls naming K203807.

Clearance record

Decision date
Received
(65 days to decision)
Product code
MAH Hearing Aid, Bone Conduction, Implanted
Regulation
21 CFR 874.3302
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Oticon Medical AB Datavagen 37b, Askim, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MAH

Trailing 12 months
1 clearance under product code MAH in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MAH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260