510(k) · Cleared
ClearedP.O.G.S. 3.3 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 Feb 12, 2002 as substantially equivalent to K014078 (On Site Gas Systems, Inc., 2002) and 2 other predicates after an 8-day review. Its family tree reaches back 4 generations to 1994. 6 later devices descend from it.
- Decided
- Feb 12, 2002
- Review
- 8 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K933081 (1994). 7 ancestors in all, the oldest K904087 (1990). 6 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- 3 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
- 2 generations backK011844 Merits Health Products Oxygen ConcentratorsMerits Health Products., Inc. · 2001
- 1 generation backK014078 ON Site Gas Systems Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002
- This deviceK020362 P.O.G.S. 3.3 Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK030920 POGS 33On Site Gas Systems, Inc. · 2004
- Descendant · 2 generations on · 3 of its ownK041664 Portable Oxygen Generation System: Pogs 33COn Site Gas Systems, Inc. · 2004
- Descendant · 3 generations on · 2 of its ownK063454 Pogs, Model 33COn Site Gas Systems, Inc. · 2007
- Descendant · 4 generations on · 0 of its ownK101154 Centrox, Reliant, Ultrox, as-D+, as-E, as-G, as-J, as-K and as-LAirsep Corp. · 2011
- Descendant · 4 generations on · 0 of its ownK092636 Pogs, Model 65/130On Site Gas Systems, Inc. · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K030920POGS 33On Site Gas Systems, Inc. · 2004 · cites it directly4descendants
- K041664Portable Oxygen Generation System: Pogs 33COn Site Gas Systems, Inc. · 2004 · 2 generations on3descendants
- K063454Pogs, Model 33COn Site Gas Systems, Inc. · 2007 · 3 generations on2descendants
- K101154Centrox, Reliant, Ultrox, as-D+, as-E, as-G, as-J, as-K and as-LAirsep Corp. · 2011 · 4 generations on0descendants
- K092636Pogs, Model 65/130On Site Gas Systems, Inc. · 2010 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933081 | Oxlife Oxygen Concentrator | Oxlife, Inc. | 1994 | — |
| −3 | K955549 | Oxlife Oxygen Concentrators | Oxlife, Inc. | 1996 | — |
| −2 | K011844 | Merits Health Products Oxygen Concentrators | Merits Health Products., Inc. | 2001 | — |
| −1 | K014078 | ON Site Gas Systems Portable Oxygen Generator System | On Site Gas Systems, Inc. | 2002 | — |
| 0 (this device) | K020362 | P.O.G.S. 3.3 Portable Oxygen Generator System | On Site Gas Systems, Inc. | 2002 | — |
| +1 | K030920 | POGS 33 | On Site Gas Systems, Inc. | 2004 | — |
| +2 | K041664 | Portable Oxygen Generation System: Pogs 33C | On Site Gas Systems, Inc. | 2004 | — |
| +3 | K063454 | Pogs, Model 33C | On Site Gas Systems, Inc. | 2007 | — |
| +4 | K101154 | Centrox, Reliant, Ultrox, as-D+, as-E, as-G, as-J, as-K and as-L | Airsep Corp. | 2011 | — |
| +4 | K092636 | Pogs, Model 65/130 | On Site Gas Systems, Inc. | 2010 | — |
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 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K014078 | ON Site Gas Systems Portable Oxygen Generator SystemSummary page 2…11 Classification Name Portable Oxygen Generator 10-1 K 00362 10.12 10.13 10.14 10.15 Legally Marketed Device Claiming Substantial Equivalency To: K 014078 On Site Gas Systems Portable Oxygen Generation System K 011844 Merits Health Products Oxygen Concentrators K 956549 Oxlife Oxyge… | 2002 |
| * | K011844 | Merits Health Products Oxygen ConcentratorsSummary page 2…10.12 10.13 10.14 10.15 Legally Marketed Device Claiming Substantial Equivalency To: K 014078 On Site Gas Systems Portable Oxygen Generation System K 011844 Merits Health Products Oxygen Concentrators K 956549 Oxlife Oxygen Concentrators Description of the Device The On Site Gas Sys… | 2001 |
| * | K955549 | Oxlife Oxygen Concentrators Our OCR of the scanned summary read K956549, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Oxlife Oxygen Concentrators”. | 1996 |
What descends from it? (6)
2 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 7 ancestors has a recall.
- Of its descendants, K030920 (On Site Gas Systems, Inc., 2004) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K014078.
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/K020362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020362: P.O.G.S. 3.3 Portable Oxygen Generator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020362
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026