Penox Technologies, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Penox Technologies, Inc.” (first 1985, latest 1987), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 84 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 |
|---|---|---|---|
| CAM | Yoke Assembly, Medical Gas | 4 | 4 |
| BYJ | Unit, Liquid-Oxygen, Portable | 2 | 2 |
| INO | Chair, Positioning, Electric | 2 | 2 |
| FNJ | Bed, Manual | 1 | 1 |
| IOR | Wheelchair, Mechanical | 1 | 1 |
Review panels
- Anesthesiology (6)
- Physical Medicine (3)
- General Hospital (1)
Most recent Penox Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K864667 | PENOX HOSPITAL BED | FNJ | 1987-01-21 | 50 |
| K863978 | PORTABLE LIQUID OXYGEN UNIT (MODIFICATION) | BYJ | 1986-12-15 | 62 |
| K862654 | MODIFIED PENOX LIFT CHAIR | INO | 1986-07-18 | 7 |
| K853775 | PENOX HIGH FLOW MANIFOLD | BYJ | 1985-11-29 | 80 |
| K852109 | PENOX PERFORMER WHEELCHAIR | IOR | 1985-08-22 | 99 |
| K851218 | PENOX LIFT CHAIR | INO | 1985-06-21 | 87 |
| K851219 | FILL HOSE SAFETY ADAPTER | CAM | 1985-06-18 | 84 |
| K851217 | PENOX DUAL FLOW MINIFOLD | CAM | 1985-06-18 | 84 |
| K851216 | PENOX DUAL FEED MANIFOLD | CAM | 1985-06-18 | 84 |
| K851215 | T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER | CAM | 1985-06-18 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Penox 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 Penox Technologies, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Penox Technologies, Inc.” (first 1985, latest 1987), across 5 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 Penox Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Penox Technologies, Inc. is 84 days.
Which FDA product codes appear under Penox Technologies, Inc.?
The most frequent FDA product codes under this applicant name are CAM (Yoke Assembly, Medical Gas, 4); BYJ (Unit, Liquid-Oxygen, Portable, 2); INO (Chair, Positioning, Electric, 2).
Next steps
- See all 10 Penox Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAM, Penox 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.