Oxlife, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Oxlife, Inc.” (first 1994, latest 2008), across 1 product code in 1 review panel. Median 510(k) review time under this name: 96 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 |
|---|---|---|---|
| CAW | Generator, Oxygen, Portable | 5 | 5 |
Review panels
- Anesthesiology (5)
Most recent Oxlife, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080082 | OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS | CAW | 2008-04-16 | 96 |
| K060922 | OXLIFE FREEDOM FIVE OXYGEN CONCENTRATORS, MODEL KXF5 | CAW | 2006-05-30 | 56 |
| K971964 | OXLIFE EXCELL OXYGEN CONCENTRATORS | CAW | 1997-08-15 | 79 |
| K955549 | OXLIFE OXYGEN CONCENTRATORS | CAW | 1996-03-15 | 101 |
| K933081 | OXLIFE OXYGEN CONCENTRATOR | CAW | 1994-11-01 | 496 |
Recalls
openFDA lists no recalls under a recalling firm named Oxlife, 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 Oxlife, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Oxlife, Inc.” (first 1994, latest 2008), across 1 product code 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 Oxlife, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oxlife, Inc. is 96 days.
Which FDA product codes appear under Oxlife, Inc.?
The most frequent FDA product codes under this applicant name are CAW (Generator, Oxygen, Portable, 5).
Next steps
- See all 5 Oxlife, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAW, Oxlife, 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.