Transtracheal Systems: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Transtracheal Systems” (first 1986, latest 1999), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 112 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 | 0 | — |
| 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 |
|---|---|---|---|
| BTO | Tube, Tracheostomy (W/Wo Connector) | 3 | 3 |
| NFB | Conserver, Oxygen | 2 | 2 |
| CAW | Generator, Oxygen, Portable | 1 | 1 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 | 1 |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | 1 | 1 |
Review panels
- Anesthesiology (6)
- Cardiovascular (2)
Most recent Transtracheal Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982943 | TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000 | NFB | 1999-07-12 | 325 |
| K981078 | TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000 | CAW | 1998-07-23 | 121 |
| K981080 | SCOOP 1 | BTO | 1998-06-17 | 85 |
| K962944 | TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000) | NFB | 1996-10-23 | 89 |
| K904749 | TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200 | DRQ | 1991-03-01 | 133 |
| K904748 | TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100 | DRG | 1991-03-01 | 133 |
| K902281 | MODIFIED SCOOP TRANSTRACHEAL CATHETERS | BTO | 1990-08-10 | 80 |
| K854252 | TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER | BTO | 1986-02-03 | 104 |
Recalls
openFDA lists no recalls under a recalling firm named Transtracheal Systems.
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 Transtracheal Systems?
FDA lists 8 510(k) clearances under the applicant name “Transtracheal Systems” (first 1986, latest 1999), across 5 product codes in 2 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 Transtracheal Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Transtracheal Systems is 112 days.
Which FDA product codes appear under Transtracheal Systems?
The most frequent FDA product codes under this applicant name are BTO (Tube, Tracheostomy (W/Wo Connector), 3); NFB (Conserver, Oxygen, 2); CAW (Generator, Oxygen, Portable, 1).
Next steps
- See all 8 Transtracheal Systems clearances with predicates and recalls
- Run predicate analysis for product code BTO, Transtracheal Systems'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.