Pentair Filtration Solutions
Saint Paul, MN, US
Pentair Filtration Solutions appears in FDA device records in Saint Paul, MN. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Pentair Filtration Solutions carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Porous Media Corp.510(k), recall
510(k) clearance history
FDA records hold 9 510(k) clearances for Pentair Filtration Solutions between 1994 and 2006. The busiest year on record is 1997, with 2. The most recent is 2006, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1995 | 1 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 2 |
| 2006 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K062091 | POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION | BTT | Substantially Equivalent | |
| K061426 | OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47 | CAH | Substantially Equivalent | |
| K990276 | POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER | KRJ | Substantially Equivalent | |
| K982385 | POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER | KRJ | Substantially Equivalent | |
| K982127 | POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER | CAH | Substantially Equivalent | |
| K965020 | POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER | CAH | Substantially Equivalent | |
| K964979 | POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER | CAH | Substantially Equivalent | |
| K952428 | POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER | CAH | Substantially Equivalent | |
| K934132 | POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER | CAH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2132517 | 1000221012 | Pentair Filtration Solutions | 1350 Hammond Rd, Saint Paul, MN 55110 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0935-2007 | 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) | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
