Porous Media Corp.
United StatesFDA applicant, unverified
- Devices
- 9
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Porous Media Corp. makes
Porous Media Corp. manufactures disposable and reusable respiratory filters, including pre-bypass filters for medical gas delivery systems and filters for oxygen concentrators. Their product line also includes a humidifier designed for universal humidification in respiratory therapy applications. All devices are engineered to filter airborne particles and contaminants from inhaled gases.
The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. Their products are intended for use in the United States and comply with applicable medical device standards for filtration and respiratory support systems.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Porous Media DBF23 Disposable Respiratory Filter Ref K964979
Regimes: 510(k) Registry: 510(k)Porous Media DBF23 Disposable Respiratory Filter Ref K934132
Regimes: 510(k) Registry: 510(k)Porous Media DEF25 Disposable Respiratory Filter Ref K982127
Regimes: 510(k) Registry: 510(k)Porous Media DBF23-R Reusable Respiratory Filter Ref K952428
Regimes: 510(k) Registry: 510(k)Porous Media DBF23 Reusable Respiratory Filter Ref K965020
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Porous Media Corp., initiated on 2007-04-26. By recorded status: 1 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.
2007
- 26 Apr 2007 Z-0935-2007 Unclassified (pre-2012) Terminated The Intake filter of the Humidiflow kits may became detached from the module and fall onto the compressor cooling fan during patient treatment. (If the filter were to come in contact with the fan blades this could stop the fan from operating and cause the concentrator to overheat and interrupt the flow of oxygen to the patient)
Full distribution text
- 26 Apr 2007 Z-0935-2007 Unclassified (pre-2012) Terminated The Intake filter of the Humidiflow kits may became detached from the module and fall onto the compressor cooling fan during patient treatment. (If the filter were to come in contact with the fan blades this could stop the fan from operating and cause the concentrator to overheat and interrupt the flow of oxygen to the patient)
Frequently asked questions
How many devices does Porous Media Corp. have in the registry?
The registry currently lists 9 devices for Porous Media Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Porous Media Corp.'s devices?
Among its 9 most recently registered devices, Porous Media Corp. has devices listed in FDA 510(k) (9 devices).
What risk classes do Porous Media Corp.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Porous Media Corp.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Porous Media Corp.?
FDA recall records list 1 recall initiated by Porous Media Corp., the most recent initiated on 2007-04-26. 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 Porous Media Corp. in the registry?
The most recently registered devices listed for Porous Media Corp. include POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER, POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER, POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER and POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER.