510(k) · Cleared
ClearedON Site Gas Systems Portable Oxygen Generation System-1.0 and 5.0
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 May 22, 2002 as substantially equivalent to K020362 (On Site Gas Systems, Inc., 2002) and 1 other predicate after a 49-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- May 22, 2002
- Review
- 49 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K933081 (1994). 8 ancestors in all, the oldest K904087 (1990). No later device cites it as a predicate yet.
- Root · 5 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- 4 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
- 3 generations backK011844 Merits Health Products Oxygen ConcentratorsMerits Health Products., Inc. · 2001
- 2 generations backK014078 ON Site Gas Systems Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002
- 1 generation backK020362 P.O.G.S. 3.3 Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002
- This deviceK021082 ON Site Gas Systems Portable Oxygen Generation System-1.0 and 5.0On Site Gas Systems, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933081 | Oxlife Oxygen Concentrator | Oxlife, Inc. | 1994 | — |
| −4 | K955549 | Oxlife Oxygen Concentrators | Oxlife, Inc. | 1996 | — |
| −3 | K011844 | Merits Health Products Oxygen Concentrators | Merits Health Products., Inc. | 2001 | — |
| −2 | 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 | — |
| 0 (this device) | K021082 | ON Site Gas Systems Portable Oxygen Generation System-1.0 and 5.0 | On Site Gas Systems, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1997 | 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 |
|---|---|---|---|
| * | K020362 | P.O.G.S. 3.3 Portable Oxygen Generator SystemSummary page 2…Classification Name Portable Oxygen Generator 7-1 — Revised 5/20/02 7.12 713 7.14 715 Legally Marketed Device Claiming Substantial Equivalency To: K 020362 On Site Gas Systems Portable Oxygen Generation System K 014078 On Site Gas Systems Portable Oxygen Generation System Description… | 2002 |
| * | K014078 | ON Site Gas Systems Portable Oxygen Generator SystemSummary page 2…/20/02 7.12 713 7.14 715 Legally Marketed Device Claiming Substantial Equivalency To: K 020362 On Site Gas Systems Portable Oxygen Generation System K 014078 On Site Gas Systems Portable Oxygen Generation System Description of the Device The On Site Gas Systems portable oxygen generat… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 months on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K020362.
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/K021082 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021082: ON Site Gas Systems Portable Oxygen Generation System-1.0 and 5.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021082
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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