Data / Medical devices / United States / On Site Gas Systems, Inc.
On Site Gas Systems, Inc.: FDA-registered device maker in Newington, CT, United States, 4 510(k) clearances
On Site Gas Systems, Inc. is registered with the FDA (registration 3003637574) in Newington, CT, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated January 7, 2010. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003637574
- Address
- 35 Budney Rd, Newington, CT, United States, 06111
- Owner or operator
- ON SITE GAS SYSTEMS, INC. (9096051)
- Roles
- Manufacturer
- First device listed
- November 30, 2007
- Registered through
- 2026
- Brand names listed
- POGS, POGS 130, POGS 65/130, POGS10, POGS33, POGS33C
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Generator, Oxygen, Portable | CAW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 7, 2010 | K092636 | POGS, MODEL 65/130 | CAW | Substantially Equivalent | On Site Gas Systems, Inc. | accessdata.fda.gov |
| May 9, 2007 | K063454 | POGS, MODEL 33C | CAW | Substantially Equivalent | On Site Gas Systems, Inc. | accessdata.fda.gov |
| May 22, 2002 | K021082 | ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0 | CAW | Substantially Equivalent | On Site Gas Systems, Inc. | accessdata.fda.gov |
| January 8, 2002 | K014078 | ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM | CAW | Substantially Equivalent | On Site Gas Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 19, 2013 | 67132 | Class II | Terminated | On Site Gas Systems POGS 33C Portable Oxygen Generation System | Heat exchanger hose becomes weak and may fail. | accessdata.fda.gov |
Compare with other makers
Updated January 8, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.