510(k) · Cleared
ClearedPogs, Model 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 May 9, 2007 as substantially equivalent to K041664 (On Site Gas Systems, Inc., 2004) after a 175-day review. Its family tree reaches back 7 generations to 1994. 2 later devices descend from it.
- Decided
- May 9, 2007
- Review
- 175 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K933081 (1994). 11 ancestors in all, the oldest K904087 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- 6 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
- 5 generations backK011844 Merits Health Products Oxygen ConcentratorsMerits Health Products., Inc. · 2001
- 4 generations backK014078 ON Site Gas Systems Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002
- 3 generations backK020362 P.O.G.S. 3.3 Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002
- 2 generations backK030920 POGS 33On Site Gas Systems, Inc. · 2004
- 1 generation backK041664 Portable Oxygen Generation System: Pogs 33COn Site Gas Systems, Inc. · 2004
- This deviceK063454 Pogs, Model 33COn Site Gas Systems, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK101154 Centrox, Reliant, Ultrox, as-D+, as-E, as-G, as-J, as-K and as-LAirsep Corp. · 2011
- Descendant · cites it directly · 0 of its ownK092636 Pogs, Model 65/130On Site Gas Systems, Inc. · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K933081 | Oxlife Oxygen Concentrator | Oxlife, Inc. | 1994 | — |
| −6 | K955549 | Oxlife Oxygen Concentrators | Oxlife, Inc. | 1996 | — |
| −5 | K011844 | Merits Health Products Oxygen Concentrators | Merits Health Products., Inc. | 2001 | — |
| −4 | K014078 | ON Site Gas Systems Portable Oxygen Generator System | On Site Gas Systems, Inc. | 2002 | — |
| −3 | K020362 | P.O.G.S. 3.3 Portable Oxygen Generator System | On Site Gas Systems, Inc. | 2002 | — |
| −2 | K030920 | POGS 33 | On Site Gas Systems, Inc. | 2004 | — |
| −1 | K041664 | Portable Oxygen Generation System: Pogs 33C | On Site Gas Systems, Inc. | 2004 | — |
| 0 (this device) | K063454 | Pogs, Model 33C | On Site Gas Systems, Inc. | 2007 | — |
| +1 | K101154 | Centrox, Reliant, Ultrox, as-D+, as-E, as-G, as-J, as-K and as-L | Airsep Corp. | 2011 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K041664 | Portable Oxygen Generation System: Pogs 33CSummary page 1…lass 11 Product Code: CAW Classification Panel: Anesthesiology Regulation Number: 21 CFR 868.5440 Predicate Devices: POGS 33. 510(k) K041664, On-Site Gas Systems, Inc. Description of Device: The Portable Oxygen Generation System 33 (POGS 33C) has been designed to accom… | 2004 |
What descends from it? (2)
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 13 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K101154 (Airsep Corp., 2011) has gone furthest, with 0 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. 2007, this device’s year, is highlighted.
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 generate and deliver USP 93% supplemental oxygen and medical grade air. This device is intended to be used only by trained personnel in disaster relief and emergency preparedness situations, or military settings where bottled oxygen is not readily available
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063454 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063454: Pogs, Model 33C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063454
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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