510(k) · Cleared
ClearedPatient Ventilation Oxygen Concentrating System (Pvocs)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Litton Systems, Inc. · CAW Generator, Oxygen, Portable
Cleared on Feb 11, 2002 after a 137-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Feb 11, 2002
- Review
- 137 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK013223 Patient Ventilation Oxygen Concentrating System (Pvocs)Litton 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 · cites it directly · 1 of its ownK022684 Portable Therapeutic Oxygen Concentration System (Ptocs)Essex Cryogenics of Missouri, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK131990 Oxygen Generator Liquefier - (Ogl)Essex Cryogenics of Missouri, Inc. · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · 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
- K022684Portable Therapeutic Oxygen Concentration System (Ptocs)Essex Cryogenics of Missouri, Inc. · 2002 · cites it directly1descendant
- K131990Oxygen Generator Liquefier - (Ogl)Essex Cryogenics of Missouri, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013223 | Patient Ventilation Oxygen Concentrating System (Pvocs) | Litton 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 | — |
| +1 | K022684 | Portable Therapeutic Oxygen Concentration System (Ptocs) | Essex Cryogenics of Missouri, Inc. | 2002 | — |
| +2 | K131990 | Oxygen Generator Liquefier - (Ogl) | Essex Cryogenics of Missouri, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
3 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?
- Of its descendants, K030920 (On Site Gas Systems, Inc., 2004) has gone furthest, with 4 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 PVOCS is intended to supply 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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013223: Patient Ventilation Oxygen Concentrating System (Pvocs).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013223
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026