Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Oticon Medical AB · Predicate Candidate Screening

16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

112 daysmedian FDA review time

137 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K240614	Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS	Oticon Medical AB	2024-07-10	127
K213733	Ponto 5 SuperPower	Oticon Medical AB	2021-12-16	20
K211640	Ponto 5 Mini	Oticon Medical AB	2021-08-10	75
K203807	Ponto Bone Anchored Hearing System, MONO Surgery Kit	Oticon Medical AB	2021-03-03	65
K190540	Ponto 4	Oticon Medical AB	2019-05-02	59
K161671	Ponto 3, Ponto 3 Power and Ponto 3 SuperPower	Oticon Medical AB	2016-09-29	105
K152820	Ponto Bone Anchored Hearing System	Oticon Medical AB	2016-01-22	116
K152067	Ponto bone anchored hearing system	Oticon Medical AB	2015-11-23	122
K142678	Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bo	Oticon Medical AB	2015-01-21	124
K141616	STERILIZATION CASSETTE	Oticon Medical AB	2014-09-23	99
K132775	PONTO PLUS AND PONTO PLUS POWER	Oticon Medical AB	2013-12-09	95
K121228	PONTO BONE ANCHORED HEARING SYSTEM	Oticon Medical AB	2012-09-07	137
K112053	OBC BONE ANCHORED HEARING SYSTEM	Oticon Medical AB	2011-11-18	122
K103594	PONTO PRO POWER	Oticon Medical AB	2011-06-15	189
K090996	PONTO PRO	Oticon Medical AB	2009-07-29	112
K082108	OBC BONE ANCHORED HEARING AID SYSTEM	Oticon Medical AB	2008-11-14	112

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda