510(k) · Cleared
ClearedSpirit 300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caire, Inc. · BYJ Unit, Liquid-Oxygen, Portable
Cleared on Dec 18, 2001 as substantially equivalent to K800742 (Cryogenic Assoc., 1980) and 2 other predicates after an 81-day review. Its family tree reaches back 2 generations to 1994. 1 of the 12 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.
- Decided
- Dec 18, 2001
- Review
- 81 days
- Class
- Class II
- Product code
- BYJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K933930 (1994). 4 ancestors in all, the oldest K800742 (1980). 7 later devices descend from it, 3 citing it directly. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK933930 Puritan-Bennett Companion 550 Liquid Oxygen Portable UnitPuritan Bennett Corp. · 1994
- 1 generation backK993220 Puritan-Bennett Helios Portable Liquid Oxygen SystemPuritan Bennett Corp. · 1999
- This deviceK013251 Spirit 300Caire, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK072011 Copd Liquid Oxygen Portable, Model 300PCopd Partners, Inc. · 2007
- Descendant · 2 generations on · 2 of its ownK090421 Model 350G Gas ConserverInspired Technologies, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK050153 Spirit, Model HasCaire, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 0 of its ownK221014 Effortless Oxygen Conserver System Models Effortless Pro and…Effortless Oxygen, LLC · 2022
- Descendant · 3 generations on · 0 of its ownK200401 ApogeeIncoba Ltd D/B/A Dynaris · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K800742 Liberator/Stroller II Systemdirect predicate · 1980
Most influential descendants
Showing 5 of 7 · See all- K072011Copd Liquid Oxygen Portable, Model 300PCopd Partners, Inc. · 2007 · cites it directly3descendants
- K090421Model 350G Gas ConserverInspired Technologies, Inc. · 2009 · 2 generations on2descendants
- K050153Spirit, Model HasCaire, Inc. · 2005 · cites it directly1descendant
- K221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLC · 2022 · 3 generations on0descendants
- K200401ApogeeIncoba Ltd D/B/A Dynaris · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933930 | Puritan-Bennett Companion 550 Liquid Oxygen Portable Unit | Puritan Bennett Corp. | 1994 | — |
| −1 | K993220 | Puritan-Bennett Helios Portable Liquid Oxygen System | Puritan Bennett Corp. | 1999 | — |
| 0 (this device) | K013251 | Spirit 300 | Caire, Inc. | 2001 | — |
| +1 | K072011 | Copd Liquid Oxygen Portable, Model 300P | Copd Partners, Inc. | 2007 | — |
| +2 | K090421 | Model 350G Gas Conserver | Inspired Technologies, Inc. | 2009 | — |
| +1 | K050153 | Spirit, Model Has | Caire, Inc. | 2005 | 1 |
| +3 | K221014 | Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile | Effortless Oxygen, LLC | 2022 | — |
| +3 | 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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K800742 | Liberator/Stroller II SystemSummary page 1…ification Panel: Anesthesiology CFR Section: 868.5655 Product Code: BY) Legally Marked Device to Which Substantially Equivalency is Claimed: Caire Stroller [FDA 510(k) #K800742] Puritan Bennett HELIOS [FDA 510(k) #K993220] DeVilbiss LPO5PP [FDA 510(k) #K833994] Description of the Device: The Spirit 30… | 1980 |
| * | K993220 | Puritan-Bennett Helios Portable Liquid Oxygen SystemSummary page 1…68.5655 Product Code: BY) Legally Marked Device to Which Substantially Equivalency is Claimed: Caire Stroller [FDA 510(k) #K800742] Puritan Bennett HELIOS [FDA 510(k) #K993220] DeVilbiss LPO5PP [FDA 510(k) #K833994] Description of the Device: The Spirit 300 is a small, lightweight, liquid oxygen porta… | 1999 |
| * | K833994 | Pulsair I & IISummary page 1…d Device to Which Substantially Equivalency is Claimed: Caire Stroller [FDA 510(k) #K800742] Puritan Bennett HELIOS [FDA 510(k) #K993220] DeVilbiss LPO5PP [FDA 510(k) #K833994] Description of the Device: The Spirit 300 is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuum-… | 1983 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · Direct predicate · ◆ in the 1980 ancestors bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 4 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K072011 (Copd Partners, Inc., 2007) has gone furthest, with 3 descendants of its own.
How does its category compare?
All BYJ devicesBYJ Unit, Liquid-Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 CAIRE Spirit 300 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 Spirit 300 is neither a ||fe sustaining nor life supporting device.
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/K013251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013251: Spirit 300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013251
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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