Porex Medical: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Porex Medical” (first 1983, latest 1987), across 13 product codes in 3 review panels. Median 510(k) review time under this name: 39 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 |
|---|---|---|---|
| FWP | Prosthesis, Chin, Internal | 2 | 2 |
| ETN | Stimulator, Nerve | 1 | 1 |
| FSE | Table, Operating-Room, Manual | 1 | 1 |
| FZD | Prosthesis, Ear, Internal | 1 | 1 |
| FZE | Prosthesis, Nose, Internal | 1 | 1 |
| FZZ | Marker, Skin | 1 | 1 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 1 | 1 |
| HPZ | Implant, Eye Sphere | 1 | 1 |
| HQX | Implant, Orbital, Extra-Ocular | 1 | 1 |
| KDG | Chisel (Osteotome) | 1 | 1 |
Plus 3 more product codes.
Review panels
Most recent Porex Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K872791 | POREX NERVE LOCATOR | ETN | 1987-10-20 | 98 |
| K873044 | POREX OTOLOGY INSTRUMENTS | LRC | 1987-09-04 | 31 |
| K872947 | POREX QUALITY PLASTIC SURGERY INSTRUMENTS | KDG | 1987-08-21 | 24 |
| K863946 | POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT | HQX | 1987-02-27 | 140 |
| K863943 | POREX(TM) EYE SPHERE IMPLANT | HPZ | 1987-02-27 | 140 |
| K870257 | POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T. | — | 1987-02-24 | 32 |
| K870182 | POREX(TM) MALAR IMPLANT | — | 1987-02-24 | 39 |
| K870154 | POREX(TM) TISSUE EXPANDER | LCJ | 1987-02-24 | 42 |
| K863942 | POREX(TM) NOSE PROSTHESIS | FZE | 1986-10-24 | 14 |
| K863941 | POREX(TM) PROSTHESIS, CHIN, INTERNAL | FWP | 1986-10-24 | 14 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Porex Medical.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Porex Surgical, Inc. (19 510(k)s)
- Porex Technologies Corp. (2 510(k)s)
- Porex Technologies Corp. of Georgia (2 510(k)s)
- Porex Medical Products (1 510(k)s)
- Porex Surgical Products Group (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Porex Medical?
FDA lists 15 510(k) clearances under the applicant name “Porex Medical” (first 1983, latest 1987), across 13 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 Porex Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Porex Medical is 39 days.
Which FDA product codes appear under Porex Medical?
The most frequent FDA product codes under this applicant name are FWP (Prosthesis, Chin, Internal, 2); ETN (Stimulator, Nerve, 1); FSE (Table, Operating-Room, Manual, 1).
Next steps
- See all 15 Porex Medical clearances with predicates and recalls
- Run predicate analysis for product code FWP, Porex Medical'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.