Porous Media Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Porous Media Corp.” (first 1994, latest 2006), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 88 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | 6 | 6 |
| KRJ | Filter, Prebypass, Cardiopulmonary Bypass | 2 | 2 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
Review panels
- General Hospital (6)
- Cardiovascular (2)
- Anesthesiology (1)
Most recent Porous Media Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062091 | POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION | BTT | 2006-08-08 | 15 |
| K061426 | OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47 | CAH | 2006-06-05 | 13 |
| K990276 | POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER | KRJ | 1999-10-01 | 246 |
| K982385 | POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER | KRJ | 1999-02-01 | 207 |
| K982127 | POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER | CAH | 1998-06-23 | 6 |
| K965020 | POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER | CAH | 1997-03-14 | 88 |
| K964979 | POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER | CAH | 1997-03-11 | 89 |
| K952428 | POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER | CAH | 1995-07-07 | 44 |
| K934132 | POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER | CAH | 1994-10-04 | 405 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2007-04-26.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Porous Media Corp.?
FDA lists 9 510(k) clearances under the applicant name “Porous Media Corp.” (first 1994, latest 2006), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Porous Media Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Porous Media Corp. is 88 days.
Which FDA product codes appear under Porous Media Corp.?
The most frequent FDA product codes under this applicant name are CAH (Filter, Bacterial, Breathing-Circuit, 6); KRJ (Filter, Prebypass, Cardiopulmonary Bypass, 2); BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 1).
Next steps
- See all 9 Porous Media Corp. clearances with predicates and recalls
- Run predicate analysis for product code CAH, Porous Media Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.