510(k) · Cleared
ClearedCentrox, Reliant, Ultrox, as-D+, as-E, as-G, as-J, as-K and as-L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airsep Corp. · CAW Generator, Oxygen, Portable
Cleared on Mar 28, 2011 as substantially equivalent to K960309 (Airsep Corp., 1997) and 1 other predicate after a 339-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Mar 28, 2011
- Review
- 339 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K933081 (1994). 12 ancestors in all, the oldest K904087 (1990). No later device cites it as a predicate yet.
- Root · 8 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- 7 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
- 6 generations backK011844 Merits Health Products Oxygen ConcentratorsMerits Health Products., Inc. · 2001
- 5 generations backK014078 ON Site Gas Systems Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002
- 4 generations backK020362 P.O.G.S. 3.3 Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002
- 3 generations backK030920 POGS 33On Site Gas Systems, Inc. · 2004
- 2 generations backK041664 Portable Oxygen Generation System: Pogs 33COn Site Gas Systems, Inc. · 2004
- 1 generation backK063454 Pogs, Model 33COn Site Gas Systems, Inc. · 2007
- This deviceK101154 Centrox, Reliant, Ultrox, as-D+, as-E, as-G, as-J, as-K and as-LAirsep Corp. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K933081 | Oxlife Oxygen Concentrator | Oxlife, Inc. | 1994 | — |
| −7 | K955549 | Oxlife Oxygen Concentrators | Oxlife, Inc. | 1996 | — |
| −6 | K011844 | Merits Health Products Oxygen Concentrators | Merits Health Products., Inc. | 2001 | — |
| −5 | K014078 | ON Site Gas Systems Portable Oxygen Generator System | On Site Gas Systems, Inc. | 2002 | — |
| −4 | K020362 | P.O.G.S. 3.3 Portable Oxygen Generator System | On Site Gas Systems, Inc. | 2002 | — |
| −3 | K030920 | POGS 33 | On Site Gas Systems, Inc. | 2004 | — |
| −2 | K041664 | Portable Oxygen Generation System: Pogs 33C | On Site Gas Systems, Inc. | 2004 | — |
| −1 | K063454 | Pogs, Model 33C | On Site Gas Systems, Inc. | 2007 | — |
| 0 (this device) | K101154 | Centrox, Reliant, Ultrox, as-D+, as-E, as-G, as-J, as-K and as-L | Airsep Corp. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1997 | 2 | 0 |
| 2002 | 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? (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 |
|---|---|---|---|
| * | K960309 | Airsep Newlife Dual Six Oxygen Concentrator (Modification)Summary page 1…Therapy Devices Predicate Devices NewLife Intensity from AirSep Corporation Product code: CAW 5 10(k) number: K960309 Portable Oxygen Generator with Medical Air (PO05 33C) from On Site Gas Systems, Inc.… | 1997 |
| * | K063454 | Pogs, Model 33CSummary page 1…Portable Oxygen Generator with Medical Air (PO05 33C) from On Site Gas Systems, Inc. Product code: CAW 5 10(k) number: K063454 Airsep Corporation 401 Creekside Drive, Buffalo, NY 14228. Phone 716 691 0202 fax 716 691 4141… | 2007 |
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 17 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 12 ancestors has a recall.
- 1 other device also cites its predicate K960309.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 intended use of the Device is to generate and deliver USP 93% oxygen for supplemental oxygen use only or filling cylinders. The device must not be used for or with any life-supporting applications.
The Device is intended to be used only by trained personnel in hospitals, health care facilities or remote locations where bottled oxygen is not readily available.
The instruction manual of the device recommends an alternate source of supplemental oxygen in the event of a power outage, alarm condition, or mechanical failure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101154: Centrox, Reliant, Ultrox, as-D+, as-E, as-G, as-J, as-K and as-L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101154
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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