Atos Medical AB: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Atos Medical AB” (first 1990, latest 2016), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 126 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 113 |
| 2014 | 1 | 122 |
| 2015 | 0 | — |
| 2016 | 1 | 262 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EWL | Prosthesis, Laryngeal (Taub) | 8 | 8 |
| JOH | Tube Tracheostomy And Tube Cuff | 3 | 3 |
| KAM | Cannula, Sinus | 3 | 3 |
| ETD | Tube, Tympanostomy | 1 | 1 |
Review panels
Most recent Atos Medical AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151404 | ProTrach Dualcare | JOH | 2016-02-12 | 262 |
| K141380 | PROVOX FREEHANDS FLEXIVOICE | EWL | 2014-09-26 | 122 |
| K131947 | PROVOX VEGA PUNCTURE SET | EWL | 2013-10-18 | 113 |
| K092593 | PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) | EWL | 2010-10-14 | 416 |
| K090455 | PROVOX VEGA, MODEL 8130-8135 | EWL | 2009-06-05 | 102 |
| K072582 | PROVOX MICRON HME | JOH | 2008-05-30 | 260 |
| K043138 | PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 | EWL | 2004-11-22 | 10 |
| K022125 | PROVOX FREEHANDS HME, MODEL 7710 | EWL | 2002-07-30 | 29 |
| K014102 | PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 | JOH | 2002-02-21 | 70 |
| K971244 | PROVOX 2 VOICE PROSTHESIS SYSTEM | EWL | 1997-06-06 | 64 |
5 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2021-03-29.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Atos Medical AB is the lead sponsor of 10 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06487104: Use of TrachPhone in Tracheostomized Patients (Enrolling by invitation, started 2025-02-05)
- NCT06084611: Long Term Effects of Heat and Moisture Exchangers (HMEs) (Completed, started 2024-03-26)
- NCT05079386: Clinical Feasibility of a New Voice Prosthesis (Completed, started 2022-01-07)
- NCT04943731: Day/Night Regimen With Provox Life Heat and Moisture Exchangers (Completed, started 2021-07-26)
- NCT04974801: Assessment of the New Provox Life System for Pulmonary Health and Quality of Life After Total Laryngectomy (Completed, started 2020-12-14)
Frequently asked questions
How many FDA 510(k) clearances are listed under Atos Medical AB?
FDA lists 15 510(k) clearances under the applicant name “Atos Medical AB” (first 1990, latest 2016), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Atos Medical AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Atos Medical AB is 126 days.
Which FDA product codes appear under Atos Medical AB?
The most frequent FDA product codes under this applicant name are EWL (Prosthesis, Laryngeal (Taub), 8); JOH (Tube Tracheostomy And Tube Cuff, 3); KAM (Cannula, Sinus, 3).
Next steps
- See all 15 Atos Medical AB clearances with predicates and recalls
- Run predicate analysis for product code EWL, Atos Medical AB's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.