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

Atos Medical AB · Predicate Candidate Screening

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

126 daysmedian FDA review time

280 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K151404	ProTrach Dualcare	Atos Medical AB	2016-02-12	262
K141380	PROVOX FREEHANDS FLEXIVOICE	Atos Medical AB	2014-09-26	122
K131947	PROVOX VEGA PUNCTURE SET	Atos Medical AB	2013-10-18	113
K092593	PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)	Atos Medical AB	2010-10-14	416
K090455	PROVOX VEGA, MODEL 8130-8135	Atos Medical AB	2009-06-05	102
K072582	PROVOX MICRON HME	Atos Medical AB	2008-05-30	260
K043138	PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 71	Atos Medical AB	2004-11-22	10
K022125	PROVOX FREEHANDS HME, MODEL 7710	Atos Medical AB	2002-07-30	29
K014102	PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251	Atos Medical AB	2002-02-21	70
K971244	PROVOX 2 VOICE PROSTHESIS SYSTEM	Atos Medical AB	1997-06-06	64
K942495	SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM	Atos Medical AB	1995-02-21	280
K940638	PROVOX(TM) VOICE PROSTHESIS	Atos Medical AB	1994-06-22	128
K936275	TYMPOVENT	Atos Medical AB	1994-05-05	126
K922145	SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS	Atos Medical AB	1993-01-21	259
K896630	SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM	Atos Medical AB	1990-06-06	196

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