510(k) · Cleared
ClearedCopd Liquid Oxygen Portable, Model 300P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Copd Partners, Inc. · BYJ Unit, Liquid-Oxygen, Portable
Cleared on Oct 18, 2007 as substantially equivalent to K013251 (Caire, Inc., 2001) after an 87-day review. Its family tree reaches back 3 generations to 1994. 1 of the 9 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Oct 18, 2007
- Review
- 87 days
- Class
- Class II
- Product code
- BYJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K933930 (1994). 5 ancestors in all, the oldest K800742 (1980). 3 later devices descend from it, 1 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK933930 Puritan-Bennett Companion 550 Liquid Oxygen Portable UnitPuritan Bennett Corp. · 1994
- 2 generations backK993220 Puritan-Bennett Helios Portable Liquid Oxygen SystemPuritan Bennett Corp. · 1999
- 1 generation backK013251 Spirit 300Caire, Inc. · 2001
- This deviceK072011 Copd Liquid Oxygen Portable, Model 300PCopd Partners, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK090421 Model 350G Gas ConserverInspired Technologies, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK221014 Effortless Oxygen Conserver System Models Effortless Pro and…Effortless Oxygen, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK200401 ApogeeIncoba Ltd D/B/A Dynaris · 2020
Class I recalls in this family
- K800742 Liberator/Stroller II System2 generations back · 1980
Most influential descendants
Showing 3 of 3 · See all- K090421Model 350G Gas ConserverInspired Technologies, Inc. · 2009 · cites it directly2descendants
- K221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLC · 2022 · 2 generations on0descendants
- K200401ApogeeIncoba Ltd D/B/A Dynaris · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933930 | Puritan-Bennett Companion 550 Liquid Oxygen Portable Unit | Puritan Bennett Corp. | 1994 | — |
| −2 | K993220 | Puritan-Bennett Helios Portable Liquid Oxygen System | Puritan Bennett Corp. | 1999 | — |
| −1 | K013251 | Spirit 300 | Caire, Inc. | 2001 | — |
| 0 (this device) | K072011 | Copd Liquid Oxygen Portable, Model 300P | Copd Partners, Inc. | 2007 | — |
| +1 | K090421 | Model 350G Gas Conserver | Inspired Technologies, Inc. | 2009 | — |
| +2 | K221014 | Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile | Effortless Oxygen, LLC | 2022 | — |
| +2 | K200401 | Apogee | Incoba Ltd D/B/A Dynaris | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 1 |
| 1983 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K013251 | Spirit 300Summary page 1…Portable Liquid Oxygen Unit Classification 868.5655 Product Codes BYJ Predicate Device Spirit 300 510(k) Number: K013251 Manufacturer: Caire Inc., 1800 Sandy Plains Industr… | 2001 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090421 | Model 350G Gas Conserver | 2009 | 2 |
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 · 2 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 5.6 years on median.
- 1 of the 5 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K090421 (Inspired Technologies, Inc., 2009) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K013251.
How does its category compare?
All BYJ devicesBYJ Unit, Liquid-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 · BYJ
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · BYJ
164in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BYJ
4in 2022
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · BYJ
1in 2025
MAUDE reports naming product code BYJ, 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 | 2 | — | 1 | 24 |
| 2008 | 3 | 164 | 0 | 33 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 1 | — | 0 | 24 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 11 |
| 2013 | 1 | — | 0 | 22 |
| 2014 | 0 | — | 0 | 25 |
| 2015 | 0 | — | 0 | 34 |
| 2016 | 0 | — | 0 | 19 |
| 2017 | 0 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 21 |
| 2019 | 0 | — | 0 | 24 |
| 2020 | 0 | — | 0 | 39 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 4 (4) | 4 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The COPD Partners Model 300P Liquid Oxygen Portable will provide a source of supplemental oxygen for ambulatory home healthcare patients, by vaporizing medical grade liquid oxygen, and then dispensing it to the patient via an integral electronic conserving device. The Model 300P Liquid Oxygen Portable is neither a life-sustaining nor life-supporting device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072011: Copd Liquid Oxygen Portable, Model 300P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072011
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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