510(k) · Cleared
ClearedModification to: Spirit
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 Jun 16, 2008 as substantially equivalent to K013251 (Caire, Inc., 2001) after a 164-day review. Its family tree reaches back 3 generations to 1994. 1 of the 6 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 16, 2008
- Review
- 164 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). No later device cites it as a predicate yet. 1 of the 6 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 deviceK080023 Modification to: SpiritCaire, Inc. · 2008
Class I recalls in this family
- K800742 Liberator/Stroller II System2 generations back · 1980
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) | K080023 | Modification to: Spirit | Caire, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 1 |
| 1983 | 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…CFR Section: 865.5655 Regulation Description: Portable Liquid Oxygen Unit Predicate Device: Spirit 300 [FDA 510(K) K013251] Device Description: The spirit 300 is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuum ins… | 2001 |
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 · 2 generations back · ◆ in the 1980 ancestors bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 14 years and passes through 2 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.
- 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. 2008, 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 Caire Spirit 300 will provide a source of supplemental oxygen for ambulatory
healthcare patients by vaporizing medical grade liquid oxygen and then
dispensing it to the, patient via an integral electronic conserving device (digital
oxygen conserving device-DOCID). The Spirit 300 is neither a life sustaining nor
life supporting device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080023 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080023: Modification to: Spirit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080023
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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