Permeable Technologies, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Permeable Technologies, Inc.” (first 1994, latest 1997), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 110 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 |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 6 | 6 |
| HQD | Lens, Contact (Other Material) - Daily | 1 | 1 |
Review panels
- Ophthalmic (7)
Most recent Permeable Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K963001 | LIFESTYLE 4-VUE (POLYMACON) HYDROPHILIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR | LPL | 1997-03-11 | 221 |
| K963011 | LIFESTYLE FREQUENCY PROGRESSIVE (METHAFILCON A) MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR | LPL | 1996-11-29 | 119 |
| K963010 | LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENS FOR DAILY WEAR | HQD | 1996-11-20 | 110 |
| K951893 | LIFESTYLE 55 (OCUFILCON D) HYDROPHILIC CONTACT LENS LIFESTYLE FREQUENCY 55 (OCUFILCON D) GHYDROPHILIC CONTACT LENS | LPL | 1995-11-17 | 207 |
| K950283 | LIFESTYLE 4-VUE(TM) (POLYMACON) HYDROPHILIC CONTACT LENS | LPL | 1995-02-07 | 14 |
| K945981 | LIFESTYLE 55 (METHAFILCON A) SOFT HYDROPHILIC CONTACT LENS | LPL | 1995-02-07 | 61 |
| K942494 | LIFESTYLE MULTIVUE-S (POLYMACON) SOFT HYDROPHILIC CONTACT LENS | LPL | 1994-09-08 | 106 |
Recalls
openFDA lists no recalls under a recalling firm named Permeable Technologies, Inc..
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 Permeable Technologies, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Permeable Technologies, Inc.” (first 1994, latest 1997), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Permeable Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Permeable Technologies, Inc. is 110 days.
Which FDA product codes appear under Permeable Technologies, Inc.?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 6); HQD (Lens, Contact (Other Material) - Daily, 1).
Next steps
- See all 7 Permeable Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPL, Permeable Technologies, Inc.'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.