510(k) · Cleared
ClearedDeployable Oxygen Concentration System (Docs)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pacific Consolidated Industries Llp · CAW Generator, Oxygen, Portable
Cleared on Apr 12, 2002 as substantially equivalent to K014078 (On Site Gas Systems, Inc., 2002) and 2 other predicates after a 71-day review. Its family tree reaches back 4 generations to 1994. 5 later devices descend from it.
- Decided
- Apr 12, 2002
- Review
- 71 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K933081 (1994). 9 ancestors in all, the oldest K904087 (1990). 5 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
- 3 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
- 2 generations backK011844 Merits Health Products Oxygen ConcentratorsMerits Health Products., Inc. · 2001
- 1 generation backK014078 ON Site Gas Systems Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002
- This deviceK020330 Deployable Oxygen Concentration System (Docs)Pacific Consolidated Industries Llp · 2002
- Descendant · cites it directly · 2 of its ownK040738 Mobile Oxygen Storage Tank (Most)Pacific Consolidated Industries Llp · 2004 · Recalled
- Descendant · cites it directly · 1 of its ownK061414 Expeditionary Delployable Oxygen Concentration System (Edocs)…Pacific Consolidated Industries, LLC · 2007 · Recalled
- Descendant · cites it directly · 0 of its ownK100957 Deployable Oxygen Concentration System (Docs), Model 66, Deployable…Pacific Consolidated Industries, LLC · 2011
- Descendant · cites it directly · 0 of its ownK082829 Aircraft Medical Oxygen Generation System (Amogs)Carleton Life Support Systems, Inc. · 2008 · Recalled
- Descendant · cites it directly · 0 of its ownK071904 Deployable Oxygen Generation System - Medium (Dogs-M)Carleton Life Support Systems, Inc. · 2007
Most influential descendants
Showing 5 of 5 · See all- K040738Mobile Oxygen Storage Tank (Most)Pacific Consolidated Industries Llp · 2004 · cites it directly2descendants
- K061414Expeditionary Delployable Oxygen Concentration System (Edocs), Models 120B and 30;Mobile…Pacific Consolidated Industries, LLC · 2007 · cites it directly1descendant
- K100957Deployable Oxygen Concentration System (Docs), Model 66, Deployable Oxygen CeoncentrationPacific Consolidated Industries, LLC · 2011 · cites it directly0descendants
- K082829Aircraft Medical Oxygen Generation System (Amogs)Carleton Life Support Systems, Inc. · 2008 · cites it directly0descendants
- K071904Deployable Oxygen Generation System - Medium (Dogs-M)Carleton Life Support Systems, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933081 | Oxlife Oxygen Concentrator | Oxlife, Inc. | 1994 | — |
| −3 | K955549 | Oxlife Oxygen Concentrators | Oxlife, Inc. | 1996 | — |
| −2 | K011844 | Merits Health Products Oxygen Concentrators | Merits Health Products., Inc. | 2001 | — |
| −1 | K014078 | ON Site Gas Systems Portable Oxygen Generator System | On Site Gas Systems, Inc. | 2002 | — |
| 0 (this device) | K020330 | Deployable Oxygen Concentration System (Docs) | Pacific Consolidated Industries Llp | 2002 | — |
| +1 | K040738 | Mobile Oxygen Storage Tank (Most) | Pacific Consolidated Industries Llp | 2004 | 1 |
| +1 | K061414 | Expeditionary Delployable Oxygen Concentration System (Edocs), Models 120B and… | Pacific Consolidated Industries, LLC | 2007 | 1 |
| +1 | K100957 | Deployable Oxygen Concentration System (Docs), Model 66, Deployable Oxygen… | Pacific Consolidated Industries, LLC | 2011 | — |
| +1 | K082829 | Aircraft Medical Oxygen Generation System (Amogs) | Carleton Life Support Systems, Inc. | 2008 | 1 |
| +1 | K071904 | Deployable Oxygen Generation System - Medium (Dogs-M) | Carleton Life Support Systems, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1997 | 2 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 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? (3)
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 |
|---|---|---|---|
| * | K014078 | ON Site Gas Systems Portable Oxygen Generator SystemSummary page 2…ygen Concentration System (DOCS) Predicate Legally Marketed Device Equivalence Substantial equivalence is claimed to the following legally marketed predicate devices: K014078 — Portable Oxygen Generator by On Site Gas Systems K003472 — Model 6400-OM Oxygen Concentrator by SeQual Technologies Inc. K00393… | 2002 |
| * | K003472 | Integra Oxygen Concentrators Model 6400-OMSummary page 2…d Device Equivalence Substantial equivalence is claimed to the following legally marketed predicate devices: K014078 — Portable Oxygen Generator by On Site Gas Systems K003472 — Model 6400-OM Oxygen Concentrator by SeQual Technologies Inc. K003939 — Venture IOH 200 Home Fill Il Complete Home Oxygen Syste… | 2001 |
| * | K003939 | Venture Home Fill II, Model Ioh 200Summary page 2…g legally marketed predicate devices: K014078 — Portable Oxygen Generator by On Site Gas Systems K003472 — Model 6400-OM Oxygen Concentrator by SeQual Technologies Inc. K003939 — Venture IOH 200 Home Fill Il Complete Home Oxygen System by Invacare Corporation All three devices operate on the principle o… | 2001 |
What descends from it? (5)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040738 | Mobile Oxygen Storage Tank (Most) | 2004 | 2 |
| K061414 | Expeditionary Delployable Oxygen Concentration System (Edocs), Models 120B and 30;Mobile… | 2007 | 1 |
| K100957 | Deployable Oxygen Concentration System (Docs), Model 66, Deployable Oxygen Ceoncentration | 2011 | 0 |
| K082829 | Aircraft Medical Oxygen Generation System (Amogs) | 2008 | 0 |
| K071904 | Deployable Oxygen Generation System - Medium (Dogs-M) | 2007 | 0 |
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 4 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K040738 (Pacific Consolidated Industries Llp, 2004) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K014078.
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?
DOCS is intended to provide supplementary oxygen. The device is to be used by trained medical personnel 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/K020330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020330: Deployable Oxygen Concentration System (Docs).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020330
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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