510(k) · Cleared
ClearedDeployable Oxygen Concentration System (Docs), Model 66, Deployable Oxygen Ceoncentration
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pacific Consolidated Industries, LLC · CAW Generator, Oxygen, Portable
Cleared on Jan 21, 2011 as substantially equivalent to K020330 (Pacific Consolidated Industries Llp, 2002) and 1 other predicate after a 289-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Jan 21, 2011
- Review
- 289 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K933081 (1994). 12 ancestors in all, the oldest K904087 (1990). No later device cites it as a predicate yet.
- 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 backK020330 Deployable Oxygen Concentration System (Docs)Pacific Consolidated Industries Llp · 2002
- 2 generations backK040738 Mobile Oxygen Storage Tank (Most)Pacific Consolidated Industries Llp · 2004 · Recalled
- 1 generation backK061414 Expeditionary Delployable Oxygen Concentration System (Edocs)…Pacific Consolidated Industries, LLC · 2007 · Recalled
- This deviceK100957 Deployable Oxygen Concentration System (Docs), Model 66, Deployable…Pacific Consolidated Industries, LLC · 2011
View 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 | K020330 | Deployable Oxygen Concentration System (Docs) | Pacific Consolidated Industries Llp | 2002 | — |
| −2 | 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 |
| 0 (this device) | K100957 | Deployable Oxygen Concentration System (Docs), Model 66, Deployable Oxygen… | Pacific Consolidated Industries, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1997 | 2 | 0 |
| 2001 | 2 | 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 |
|---|---|---|---|
| * | K020330 | Deployable Oxygen Concentration System (Docs)Summary page 2…tem (DOGS).Family Predicate Legally Marketed Device Equivalence Substantial equivalence is,claimed to the legally marketed predicate devices previously submitted under K020330 - Deployable Oxygen Concentration System (DOGS) and K061414 - Expeditionary Deployable Oxygen Concentration System (EDOCS) & Mobi… | 2002 |
| * | K061414 | Expeditionary Delployable Oxygen Concentration System (Edocs), Models 120B and 30;Mobile…Summary page 2…lence Substantial equivalence is,claimed to the legally marketed predicate devices previously submitted under K020330 - Deployable Oxygen Concentration System (DOGS) and K061414 - Expeditionary Deployable Oxygen Concentration System (EDOCS) & Mobile Oxygen Storage Tank (MOST). Safe Medical Devices Act (SM… | 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 5 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 12 ancestors have a recall of any class.
- 4 other devices also cite its predicate K020330.
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 Deployable Oxygen Concentration System (DOCS) Family of devices generates and delivers USP grade 93% ± 3% oxygen. The oxygen supplied by these units is for supplemental use and is not considered to be life supporting or life sustaining. DOCS Family devices may be used to fill high pressure oxygen cylinders for use in locations remote to the DOCS unit or for ambulatory patient use. These devices are to be used only by trained personnel in disaster…
Read the full statement (122 words)
The Deployable Oxygen Concentration System (DOCS) Family of devices generates and delivers USP grade 93% ± 3% oxygen. The oxygen supplied by these units is for supplemental use and is not considered to be life supporting or life sustaining.
DOCS Family devices may be used to fill high pressure oxygen cylinders for use in locations remote to the DOCS unit or for ambulatory patient use.
These devices are to be used only by trained personnel in disaster relief, crisis response or humanitarian relief situations where bottled or bulk oxygen is not readily available, as hospital backup systems, in local emergencies where disaster has rendered the primary oxygen supply unusable, or by trained military personnel in peacetime or wartime support of Armed Forces.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100957: Deployable Oxygen Concentration System (Docs), Model 66, Deployable Oxygen Ceoncentration.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100957
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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