Respire Medical
Country not established
- Devices
- 3
- FDA recalls
- 5
At a glance
Market reach
- United States
- FDA recalls
What Respire Medical makes
Respire Medical manufactures respiratory support devices, including the RESPIRE PINK SERIES (Herbst) and RESPIRE BLUE SERIES, which are designed for non-invasive ventilation and airway management in clinical settings.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
Respire Pink Series - Herbst Ref K131138
Regimes: 510(k) Registry: 510(k)Respire Clear Ref K214096
Regimes: 510(k) Registry: 510(k)Respire Blue Series Ref K111207
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 5 recalls initiated by Respire Medical, initiated on 2017-09-01. By recorded status: 5 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 5
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 1 Sep 2017 Z-1947-2018 Class II Terminated Potential for device breakage during use
- 1 Sep 2017 Z-1948-2018 Class II Terminated Potential for device breakage during use
- 1 Sep 2017 Z-1949-2018 Class II Terminated Potential for device breakage during use
- 1 Sep 2017 Z-1950-2018 Class II Terminated Potential for device breakage during use
- 1 Sep 2017 Z-1951-2018 Class II Terminated Potential for device breakage during use
Frequently asked questions
How many devices does Respire Medical have in the registry?
The registry currently lists 3 devices for Respire Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Respire Medical's devices?
Among its 3 most recently registered devices, Respire Medical has devices listed in FDA 510(k) (3 devices).
What risk classes do Respire Medical's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Respire Medical's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Respire Medical?
FDA recall records list 5 recalls initiated by Respire Medical, the most recent initiated on 1 Sep 2017. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Respire Medical in the registry?
The most recently registered devices listed for Respire Medical include RESPIRE PINK SERIES - HERBST, Respire Clear and RESPIRE BLUE SERIES.