510(k) · Cleared
ClearedPortable Oxygen Generation System: Pogs 33C
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 Jul 29, 2004 as substantially equivalent to K030920 (On Site Gas Systems, Inc., 2004) after a 41-day review. Its family tree reaches back 6 generations to 1994. 3 later devices descend from it.
- Decided
- Jul 29, 2004
- Review
- 41 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K933081 (1994). 10 ancestors in all, the oldest K904087 (1990). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- 5 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
- 4 generations backK011844 Merits Health Products Oxygen ConcentratorsMerits Health Products., Inc. · 2001
- 3 generations backK014078 ON Site Gas Systems Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002
- 2 generations backK020362 P.O.G.S. 3.3 Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002
- 1 generation backK030920 POGS 33On Site Gas Systems, Inc. · 2004
- This deviceK041664 Portable Oxygen Generation System: Pogs 33COn Site Gas Systems, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK063454 Pogs, Model 33COn Site Gas Systems, Inc. · 2007
- Descendant · 2 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 · 2 generations on · 0 of its ownK092636 Pogs, Model 65/130On Site Gas Systems, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933081 | Oxlife Oxygen Concentrator | Oxlife, Inc. | 1994 | — |
| −5 | K955549 | Oxlife Oxygen Concentrators | Oxlife, Inc. | 1996 | — |
| −4 | K011844 | Merits Health Products Oxygen Concentrators | Merits Health Products., Inc. | 2001 | — |
| −3 | K014078 | ON Site Gas Systems Portable Oxygen Generator System | On Site Gas Systems, Inc. | 2002 | — |
| −2 | 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 | — |
| 0 (this device) | K041664 | Portable Oxygen Generation System: Pogs 33C | On Site Gas Systems, Inc. | 2004 | — |
| +1 | K063454 | Pogs, Model 33C | On Site Gas Systems, Inc. | 2007 | — |
| +2 | K101154 | Centrox, Reliant, Ultrox, as-D+, as-E, as-G, as-J, as-K and as-L | Airsep Corp. | 2011 | — |
| +2 | 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 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K030920 | POGS 33Summary page 1…CAW, CFR 21 § 868.5440 Class II Legally Marketed Device to which Substantial Equivalence is claimed: Portable Oxygen Generator System: POGS 33 K030920 Description: The Portable Oxygen Generation System 33 (POGS 33C) has been designed to… | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063454 | Pogs, Model 33C | 2007 | 2 |
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 10 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K063454 (On Site Gas Systems, Inc., 2007) has gone furthest, with 2 descendants of its own.
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 33C is intended to provide medical grade air and oxygen (USP oxygen 93%) at 50 PSIG nominal and lower output pressures in hospitals, surgical suites, and other clinical settings in military facilities only. The POGS 33C is compatible with commercial oxygen-consuming equipment and accessories, including D, E, H, and K cylinder-filling accessories, ventilators, cannulas, Draeger Narkomed Anesthesia machines and Impact Univent/Eagle 754/754M Ventilators.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041664 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041664: Portable Oxygen Generation System: Pogs 33C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041664
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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