510(k) · Cleared
ClearedON Site Gas Systems Portable Oxygen Generator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
On Site Gas Systems, Inc. · CAW Generator, Oxygen, Portable
Cleared on Jan 8, 2002 as substantially equivalent to K011844 (Merits Health Products., Inc., 2001) and 1 other predicate after a 28-day review. Its family tree reaches back 3 generations to 1994. 13 later devices descend from it.
- Decided
- Jan 8, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K933081 (1994). 6 ancestors in all, the oldest K904087 (1990). 13 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- 2 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
- 1 generation backK011844 Merits Health Products Oxygen ConcentratorsMerits Health Products., Inc. · 2001
- This deviceK014078 ON Site Gas Systems Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002
- Descendant · cites it directly · 6 of its ownK020362 P.O.G.S. 3.3 Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002
- Descendant · cites it directly · 5 of its ownK020330 Deployable Oxygen Concentration System (Docs)Pacific Consolidated Industries Llp · 2002
- Descendant · 2 generations on · 4 of its ownK030920 POGS 33On Site Gas Systems, Inc. · 2004
- Descendant · 3 generations on · 3 of its ownK041664 Portable Oxygen Generation System: Pogs 33COn Site Gas Systems, Inc. · 2004
- Descendant · 4 generations on · 2 of its ownK063454 Pogs, Model 33COn Site Gas Systems, Inc. · 2007
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K020362P.O.G.S. 3.3 Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002 · cites it directly6descendants
- K020330Deployable Oxygen Concentration System (Docs)Pacific Consolidated Industries Llp · 2002 · cites it directly5descendants
- K030920POGS 33On Site Gas Systems, Inc. · 2004 · 2 generations on4descendants
- K041664Portable Oxygen Generation System: Pogs 33COn Site Gas Systems, Inc. · 2004 · 3 generations on3descendants
- K063454Pogs, Model 33COn Site Gas Systems, Inc. · 2007 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933081 | Oxlife Oxygen Concentrator | Oxlife, Inc. | 1994 | — |
| −2 | K955549 | Oxlife Oxygen Concentrators | Oxlife, Inc. | 1996 | — |
| −1 | K011844 | Merits Health Products Oxygen Concentrators | Merits Health Products., Inc. | 2001 | — |
| 0 (this device) | K014078 | ON Site Gas Systems Portable Oxygen Generator System | On Site Gas Systems, Inc. | 2002 | — |
| +1 | K020362 | P.O.G.S. 3.3 Portable Oxygen Generator System | On Site Gas Systems, Inc. | 2002 | — |
| +1 | K020330 | Deployable Oxygen Concentration System (Docs) | Pacific Consolidated Industries Llp | 2002 | — |
| +2 | K030920 | POGS 33 | On Site Gas Systems, Inc. | 2004 | — |
| +3 | K041664 | Portable Oxygen Generation System: Pogs 33C | On Site Gas Systems, Inc. | 2004 | — |
| +4 | K063454 | Pogs, Model 33C | On Site Gas Systems, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1997 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2004 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CAW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CAW device
- #1 K230052 Inogen Rove 6score 29.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011844 | Merits Health Products Oxygen ConcentratorsSummary page 2…1 P.0.GS. Classification Name Portable Oxygen Generator 10-1 10.12 10.13 10.14 10.15 Legally Marketed Device Claiming Substantial Equivalency To: K 011844 Merits Health Products Oxygen Concentrators K955549 Oxlife Oxygen Concentrators Description of the Device The On Site Gas Syst… | 2001 |
| * | K955549 | Oxlife Oxygen ConcentratorsSummary page 2…ator 10-1 10.12 10.13 10.14 10.15 Legally Marketed Device Claiming Substantial Equivalency To: K 011844 Merits Health Products Oxygen Concentrators K955549 Oxlife Oxygen Concentrators Description of the Device The On Site Gas Systems portable oxygen generator is a prescription devic… | 1996 |
What descends from it? (13)
See all 133 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K020362 (On Site Gas Systems, Inc., 2002) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K011844.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAW
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CAW
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAW
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · CAW
611in 2025
MAUDE reports naming product code CAW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 143 | 1 | 23 |
| 2008 | 11 | 90 | 3 | 25 |
| 2009 | 8 | 193 | 2 | 43 |
| 2010 | 5 | 133 | 0 | 48 |
| 2011 | 6 | 174 | 1 | 167 |
| 2012 | 5 | 148 | 0 | 395 |
| 2013 | 2 | — | 2 | 2,309 |
| 2014 | 6 | 277 | 2 | 24,538 |
| 2015 | 1 | — | 0 | 18,973 |
| 2016 | 1 | — | 1 | 3,167 |
| 2017 | 1 | — | 1 | 107 |
| 2018 | 3 | 203 | 0 | 116 |
| 2019 | 2 | — | 2 | 120 |
| 2020 | 5 | 224 | 1 | 125 |
| 2021 | 2 | — | 0 | 194 |
| 2022 | 4 | 458 | 2 | 305 |
| 2023 | 8 | 261 | 0 | 357 |
| 2024 | 2 | — | 5 (1) | 450 |
| 2025 | 12 | 178 | 1 | 611 |
| 2026 | 6 | 260 | 0 | — |
What is it indicated for?
The POGS is intended to provide supplemental oxygen. Device is to be operated by trained medical personnel only for military use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014078 · printed Nov 4, 2026
Cite this page
510(k) Report. “K014078: ON Site Gas Systems Portable Oxygen Generator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K014078
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026