Tracoe Medical GmbH: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Tracoe Medical GmbH” (first 1978, latest 2021), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 190 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 408 |
| 2017 | 0 | — |
| 2018 | 1 | 231 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 262 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tracoe Medical GmbH took a median 246 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 214 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JOH | Tube Tracheostomy And Tube Cuff | 4 | 4 |
| BSK | Cuff, Tracheal Tube, Inflatable | 2 | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 2 | 2 |
Review panels
- Anesthesiology (8)
Most recent Tracoe Medical GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203362 | TRACOE vario | JOH | 2021-08-05 | 262 |
| K172720 | TRACOE silcosoft Tracheostomy Tube | JOH | 2018-04-27 | 231 |
| K152778 | TRACOE Cuff Pressure Monitor | BSK | 2016-12-21 | 453 |
| K152865 | TRACOE smart Cuff Manager | BSK | 2016-09-27 | 363 |
| K051587 | TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470 | BTO | 2005-10-25 | 132 |
| K043160 | TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO | JOH | 2005-02-18 | 95 |
| K961449 | TRACHEOSTOMY TUBES TRACOE-FLEX | JOH | 1996-09-13 | 150 |
| K781729 | TRACHEOTOMY TUBES | BTO | 1978-10-24 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Tracoe Medical GmbH.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Tracoe Medical GmbH?
FDA lists 8 510(k) clearances under the applicant name “Tracoe Medical GmbH” (first 1978, latest 2021), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tracoe Medical GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tracoe Medical GmbH is 190 days.
Which FDA product codes appear under Tracoe Medical GmbH?
The most frequent FDA product codes under this applicant name are JOH (Tube Tracheostomy And Tube Cuff, 4); BSK (Cuff, Tracheal Tube, Inflatable, 2); BTO (Tube, Tracheostomy (W/Wo Connector), 2).
Next steps
- See all 8 Tracoe Medical GmbH clearances with predicates and recalls
- Run predicate analysis for product code JOH, Tracoe Medical GmbH'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.