510(k) · Cleared
ClearedPulsair I & II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryo Corp. · BYJ Unit, Liquid-Oxygen, Portable
Cleared on Dec 12, 1983 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Dec 12, 1983
- Review
- 21 days
- Class
- Class II
- Product code
- BYJ
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK833994 Pulsair I & IICryo Corp. · 1983
- Descendant · cites it directly · 7 of its ownK013251 Spirit 300Caire, Inc. · 2001
- Descendant · 2 generations on · 3 of its ownK072011 Copd Liquid Oxygen Portable, Model 300PCopd Partners, Inc. · 2007
- Descendant · 3 generations on · 2 of its ownK090421 Model 350G Gas ConserverInspired Technologies, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK050153 Spirit, Model HasCaire, Inc. · 2005 · Recalled
- Descendant · 4 generations on · 0 of its ownK221014 Effortless Oxygen Conserver System Models Effortless Pro and…Effortless Oxygen, LLC · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K013251Spirit 300Caire, Inc. · 2001 · cites it directly7descendants
- K072011Copd Liquid Oxygen Portable, Model 300PCopd Partners, Inc. · 2007 · 2 generations on3descendants
- K090421Model 350G Gas ConserverInspired Technologies, Inc. · 2009 · 3 generations on2descendants
- K050153Spirit, Model HasCaire, Inc. · 2005 · 2 generations on1descendant
- K221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLC · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K833994 | Pulsair I & II | Cryo Corp. | 1983 | — |
| +1 | K013251 | Spirit 300 | Caire, Inc. | 2001 | — |
| +2 | K072011 | Copd Liquid Oxygen Portable, Model 300P | Copd Partners, Inc. | 2007 | — |
| +3 | K090421 | Model 350G Gas Conserver | Inspired Technologies, Inc. | 2009 | — |
| +2 | K050153 | Spirit, Model Has | Caire, Inc. | 2005 | 1 |
| +4 | K221014 | Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile | Effortless Oxygen, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BYJ? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K013251 (Caire, Inc., 2001) has gone furthest, with 7 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 | — |
https://510kreport.com/device/K833994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K833994: Pulsair I & II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K833994
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026