Pom Medical, LLC
United Statesfrom the FDA registration address FDA FEI 3010411911
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Pom Medical, LLC makes
Pom Medical, LLC manufactures the Panoramic Oxygen Mask (POM), a Class II medical device designed for delivering oxygen therapy to patients.
The Panoramic Oxygen Mask is regulated under the FDA’s 510(k) pathway as a Class II device and is listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Panoramic Oxygen Mask (POM) Ref K172365
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3010411911
- Address
- 5456 Endeavor Court, Moorpark, CA, 93021
FDA recalls
FDA recall records list 1 recall initiated by Pom Medical, LLC, initiated on 2018-07-11. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. 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 0
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 11 Jul 2018 Z-0262-2020 Class II Terminated Complaints were received on the product, such as the re-breather bag would not fill/inflate or the oxygen line pops off after the oxygen is turned on due to a clogged port.
Frequently asked questions
How many devices does Pom Medical, LLC have in the registry?
The registry currently lists 1 device for Pom Medical, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pom Medical, LLC's devices?
Among its 1 most recently registered device, Pom Medical, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Pom Medical, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Pom Medical, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Pom Medical, LLC?
FDA recall records list 1 recall initiated by Pom Medical, LLC, the most recent initiated on 11 Jul 2018. 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 Pom Medical, LLC in the registry?
The most recently registered devices listed for Pom Medical, LLC include Panoramic Oxygen Mask (POM).