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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

510(k) clearances
9
PMA records
0
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA 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
510(k) clearance decisions for Pentair Filtration Solutions, by decision year
YearClearances
19941
19951
19972
19981
19992
20062
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K062091POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATIONBTTSubstantially Equivalent
K061426OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47CAHSubstantially Equivalent
K990276POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTERKRJSubstantially Equivalent
K982385POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTERKRJSubstantially Equivalent
K982127POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTERCAHSubstantially Equivalent
K965020POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTERCAHSubstantially Equivalent
K964979POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTERCAHSubstantially Equivalent
K952428POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTERCAHSubstantially Equivalent
K934132POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTERCAHSubstantially Equivalent

Registered establishments

FDA registered establishments for Pentair Filtration Solutions, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
21325171000221012Pentair Filtration Solutions1350 Hammond Rd, Saint Paul, MN 55110 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0935-2007HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350 Hammond Road St Paul, MN 55110, Part Number HMK-RMThe 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