# Tracoe Medical GmbH

- Location (FDA's records): Nieder-Olm, DE
- FDA decisions: 8 (1978–2021): 8 510(k) clearances
- Product codes: JOH (4), BTO (2), BSK (2)
- 510(k) review time since 2016: median 363 days, against 376 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 20 (2 its own); citations of its devices by later devices: 7 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Shiley, Inc.: 7 (https://510kreport.com/company/shiley)
- Bivona Medical Technologies: 4 (https://510kreport.com/company/bivona-medical-technologies)
- Concord/Portex: 2 (https://510kreport.com/company/concord-portex)
- Respironics, Inc.: 1 (https://510kreport.com/company/respironics)
- Extracorporeal Medical Specialities, Inc.: 1 (https://510kreport.com/company/extracorporeal-medical-specialities)
- Mallinckrodt Medical Tpi, Inc.: 1 (https://510kreport.com/company/mallinckrodt-medical-tpi)
- Smiths Medical Asd, Inc.: 1 (https://510kreport.com/company/smiths-medical-asd)
- Rusch Intl.: 1 (https://510kreport.com/company/rusch-intl)

## Firms that cite its devices most
- Primed Halberstadt Medizintechnik GmbH: 4 (https://510kreport.com/company/primed-halberstadt-medizintechnik)
- Andreas Fahl Medizintechnik-Vertrieb GmbH: 1 (https://510kreport.com/company/andreas-fahl-medizintechnik-vertrieb)

## Its most-cited devices
- K781729: Tracheotomy Tubes (1978), cited by 2
- K961449: Tracheostomy Tubes Tracoe-Flex (1996), cited by 2
- K051587: Tracoe-Vario Tracheostomy Tubes (Various) Reference Models:  450, 455, 460, 465, 470 (2005), cited by 2
- K043160: Tracoe Phon Assist I - Speaking Valves, Reference Models: Phon Assist I-650-T/to and 650-S/SO (2005), cited by 1

## Recent decisions
- K203362: TRACOE vario (Aug 5, 2021)
- K172720: TRACOE silcosoft Tracheostomy Tube (Apr 27, 2018)
- K152778: TRACOE Cuff Pressure Monitor (Dec 21, 2016)
- K152865: TRACOE smart Cuff Manager (Sep 27, 2016)
- K051587: Tracoe-Vario Tracheostomy Tubes (Various) Reference Models:  450, 455, 460, 465, 470 (Oct 25, 2005)
- K043160: Tracoe Phon Assist I - Speaking Valves, Reference Models: Phon Assist I-650-T/to and 650-S/SO (Feb 18, 2005)
- K961449: Tracheostomy Tubes Tracoe-Flex (Sep 13, 1996)
- K781729: Tracheotomy Tubes (Oct 24, 1978)

Source page: https://510kreport.com/company/tracoe-medical