510(k) · Cleared
ClearedModel 300D Home Oxygen Liquefier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Copd Partners, Inc. · CAW Generator, Oxygen, Portable
Cleared on Aug 21, 2007 as substantially equivalent to K042944 (In-X Corporation, 2005) and 1 other predicate after an 88-day review. Its family tree reaches back 4 generations to 1994. 1 of the 9 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 21, 2007
- Review
- 88 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K933930 (1994). 8 ancestors in all, the oldest K800742 (1980). No later device cites it as a predicate yet. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK933930 Puritan-Bennett Companion 550 Liquid Oxygen Portable UnitPuritan Bennett Corp. · 1994
- 3 generations backK993220 Puritan-Bennett Helios Portable Liquid Oxygen SystemPuritan Bennett Corp. · 1999
- 2 generations backK013251 Spirit 300Caire, Inc. · 2001
- 1 generation backK050153 Spirit, Model HasCaire, Inc. · 2005 · Recalled
- This deviceK071461 Model 300D Home Oxygen LiquefierCopd Partners, Inc. · 2007
Class I recalls in this family
- K800742 Liberator/Stroller II System3 generations back · 1980
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933930 | Puritan-Bennett Companion 550 Liquid Oxygen Portable Unit | Puritan Bennett Corp. | 1994 | — |
| −3 | K993220 | Puritan-Bennett Helios Portable Liquid Oxygen System | Puritan Bennett Corp. | 1999 | — |
| −2 | K013251 | Spirit 300 | Caire, Inc. | 2001 | — |
| −1 | K050153 | Spirit, Model Has | Caire, Inc. | 2005 | 1 |
| 0 (this device) | K071461 | Model 300D Home Oxygen Liquefier | Copd Partners, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 1 |
| 1983 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K042944 | Home-Away System, Model 1041Summary page 1…Portable Classification 868.5440/868.5655 Product Codes CAW/BJY Predicate Device In-X Corporation Home-Away System Model 1041 (K042944) Caire Spirit 300 HAS (K050153) Device Description The COPD) Partners… | 2005 |
| * | K050153 | Spirit, Model HasSummary page 1…/868.5655 Product Codes CAW/BJY Predicate Device In-X Corporation Home-Away System Model 1041 (K042944) Caire Spirit 300 HAS (K050153) Device Description The COPD) Partners' model 300D is a home oxygen liquefaction device. The p… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K800742Liberator/Stroller II SystemCryogenic Assoc. · 1980 · 3 generations back · ◆ in the 1980 ancestors bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
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 Model 300D Home Oxygen Liquefier is intended for use in liquefying oxygen supplied by a concentrator equipped with an oxygen sensing device. The concentrator used with the home oxygen liquefier should generate >90% oxygen purity nominally, and alert the user if this purity drops to unacceptable levels. This liquid oxygen is intended for use with the liquid portable products rated for 93% oxygen such as the Caire Spirit 300 HAS product. This system and the associated portable are intended for use with 93% (+3%) oxygen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071461: Model 300D Home Oxygen Liquefier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071461
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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