Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
On Site Gas Systems, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
352 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092636 | POGS, MODEL 65/130 | On Site Gas Systems, Inc. | 2010-01-07 | 133 | 0 |
| K063454 | POGS, MODEL 33C | On Site Gas Systems, Inc. | 2007-05-09 | 175 | 0 |
| K041664 | PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C | On Site Gas Systems, Inc. | 2004-07-29 | 41 | 0 |
| K030920 | POGS 33 | On Site Gas Systems, Inc. | 2004-03-10 | 352 | 0 |
| K021581 | HEMOSORB | On Site Gas Systems, Inc. | 2002-07-12 | 59 | 0 |
| K013390 | QUICKCLOT | On Site Gas Systems, Inc. | 2002-05-23 | 220 | 0 |
| K021082 | ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AN | On Site Gas Systems, Inc. | 2002-05-22 | 49 | 0 |
| K020362 | P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM | On Site Gas Systems, Inc. | 2002-02-12 | 8 | 0 |
| K014078 | ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM | On Site Gas Systems, Inc. | 2002-01-08 | 28 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda