Data / Medical devices / United States / Pentair Filtration Solutions
Pentair Filtration Solutions: FDA-registered device maker in Saint Paul, MN, United States, 8 510(k) clearances
Pentair Filtration Solutions is registered with the FDA (registration 2132517) in Saint Paul, MN, United States. It lists 3 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 8, 2006. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2132517
- FEI number
- 1000221012
- Address
- 1350 Hammond Rd, Saint Paul, MN, United States, 55110
- Owner or operator
- Pentair Filtration Solutions (9009435)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 7, 2006
- Registered through
- 2026
- Brand names listed
- DBF23 DISPOSABLE RESPIRATORY FILTER, DBF23 Disposble Main Flow Filter, DBF23 Reuseable Respiratory Filter, DBF23-R Reuseable Main Flow Filter, DBF32, DBF24, DBF27,DBF25, DFC06, D, DPB30 Disposable Pre-Bypass Filter, DPC20 Disposable Pre-Bypass Filter, HUMIDIFLOW
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Filter, Prebypass, Cardiopulmonary Bypass | KRJ | 2 | Manufacturer | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 8, 2006 | K062091 | POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION | BTT | Substantially Equivalent | Porous Media Corp. | accessdata.fda.gov |
| June 5, 2006 | K061426 | OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47 | CAH | Substantially Equivalent | Porous Media Corp. | accessdata.fda.gov |
| October 1, 1999 | K990276 | POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER | KRJ | Substantially Equivalent | Porous Media Corp. | accessdata.fda.gov |
| February 1, 1999 | K982385 | POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER | KRJ | Substantially Equivalent | Porous Media Corp. | accessdata.fda.gov |
| March 14, 1997 | K965020 | POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER | CAH | Substantially Equivalent | Porous Media Corp. | accessdata.fda.gov |
| March 11, 1997 | K964979 | POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER | CAH | Substantially Equivalent | Porous Media Corp. | accessdata.fda.gov |
| July 7, 1995 | K952428 | POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER | CAH | Substantially Equivalent | Porous Media Corp. | accessdata.fda.gov |
| October 4, 1994 | K934132 | POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER | CAH | Substantially Equivalent | Porous Media Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 26, 2007 | 37863 | Not yet classified | Terminated | HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350 Hammond Road St Paul, MN 55110, Part Number HMK-RM | 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) | accessdata.fda.gov |
Compare with other makers
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
Updated June 20, 2007. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.