510(k) Report

FDA applicant

Porous Media Corp.

St. Paul, MN9 decisions1994–20061 recall

FDA records 9 decisions for Porous Media Corp. (St. Paul, MN) from 1994 to 2006: 9 510(k) clearances. Most are in product codes CAH (Filter, Bacterial, Breathing-Circuit) and KRJ (Filter, Prebypass, Cardiopulmonary Bypass). Its devices cite 8 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Porous Media Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Porous Media Corp. since 2007.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Porous Media Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Porous Media Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • CAHFilter, Bacterial, Breathing-Circuit6decisions
  • KRJFilter, Prebypass, Cardiopulmonary Bypass2decisions
  • BTTHumidifier, Respiratory Gas, (Direct Patient Interface)1decision

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K964979Porous Media DBF23 Disposable Respiratory FilterPorous Media Corp. · 19973cite it
  • K061426Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47Porous Media Corp. · 20062cite it

What has FDA decided for it lately?

  • K062091Porous Media Humidiflow Humidifier for Universal HumidificationPorous Media Corp. · 20061 recall
  • K061426Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47Porous Media Corp. · 2006
  • K990276Porous Media DPB30 Series Disposable Pre-Bypass FilterPorous Media Corp. · 1999
  • K982385Porous Media DPB20 Series Disposable Pre-Bypass FilterPorous Media Corp. · 1999
  • K982127Porous Media DEF25 Disposable Respiratory FilterPorous Media Corp. · 1998
  • K965020Porous Media DBF23 Reusable Respiratory FilterPorous Media Corp. · 1997
  • K964979Porous Media DBF23 Disposable Respiratory FilterPorous Media Corp. · 1997
  • K952428Porous Media DBF23-R Reusable Respiratory FilterPorous Media Corp. · 1995

All 9 as Porous Media Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K062091HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350…Apr 26, 2007