On Site Gas Systems, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “On Site Gas Systems, Inc.” (first 2002, latest 2010), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 59 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 | 7 | 7 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | 2 | 2 |
Review panels
Most recent On Site Gas Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092636 | POGS, MODEL 65/130 | CAW | 2010-01-07 | 133 |
| K063454 | POGS, MODEL 33C | CAW | 2007-05-09 | 175 |
| K041664 | PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C | CAW | 2004-07-29 | 41 |
| K030920 | POGS 33 | CAW | 2004-03-10 | 352 |
| K021581 | HEMOSORB | QSY | 2002-07-12 | 59 |
| K013390 | QUICKCLOT | QSY | 2002-05-23 | 220 |
| K021082 | ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0 | CAW | 2002-05-22 | 49 |
| K020362 | P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM | CAW | 2002-02-12 | 8 |
| K014078 | ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM | CAW | 2002-01-08 | 28 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2013-12-19.
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 On Site Gas Systems, Inc.?
FDA lists 9 510(k) clearances under the applicant name “On Site Gas Systems, Inc.” (first 2002, latest 2010), across 2 product codes in 2 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 On Site Gas Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name On Site Gas Systems, Inc. is 59 days.
Which FDA product codes appear under On Site Gas Systems, Inc.?
The most frequent FDA product codes under this applicant name are CAW (Generator, Oxygen, Portable, 7); QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics, 2).
Next steps
- See all 9 On Site Gas Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAW, On Site Gas Systems, 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.