510(k) · Cleared
ClearedGenerator, Oxygen, Portable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jet Research Center, Inc. · CAW Generator, Oxygen, Portable
Cleared on Jan 26, 1978 after a 23-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
- Jan 26, 1978
- Review
- 23 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK780020 Generator, Oxygen, PortableJet Research Center, Inc. · 1978
- Descendant · cites it directly · 7 of its ownK982243 Canogen Portable Oxygen Generator Model 615Canogen International, Ltd. · 1998
- Descendant · 2 generations on · 5 of its ownK052396 Oxysure Portable Oxygen Generator, Model 615Oxysure Systems, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 2 of its ownK062153 Portable Oxygen Generator SystemMolecular Products, Ltd. · 2006
- Descendant · 4 generations on · 1 of its ownK131016 ROGSMolecular Products, Ltd. · 2013
- Descendant · 5 generations on · 0 of its ownK240561 Rugged Oxygen Generator (ROG) (RO01-00001)Molecular Products, Ltd. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K982243Canogen Portable Oxygen Generator Model 615Canogen International, Ltd. · 1998 · cites it directly7descendants
- K052396Oxysure Portable Oxygen Generator, Model 615Oxysure Systems, Inc. · 2005 · 2 generations on5descendants
- K062153Portable Oxygen Generator SystemMolecular Products, Ltd. · 2006 · 3 generations on2descendants
- K131016ROGSMolecular Products, Ltd. · 2013 · 4 generations on1descendant
- K240561Rugged Oxygen Generator (ROG) (RO01-00001)Molecular Products, Ltd. · 2024 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K780020 | Generator, Oxygen, Portable | Jet Research Center, Inc. | 1978 | — |
| +1 | K982243 | Canogen Portable Oxygen Generator Model 615 | Canogen International, Ltd. | 1998 | — |
| +2 | K052396 | Oxysure Portable Oxygen Generator, Model 615 | Oxysure Systems, Inc. | 2005 | 1 |
| +3 | K062153 | Portable Oxygen Generator System | Molecular Products, Ltd. | 2006 | — |
| +4 | K131016 | ROGS | Molecular Products, Ltd. | 2013 | — |
| +5 | K240561 | Rugged Oxygen Generator (ROG) (RO01-00001) | Molecular Products, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2024 | 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 CAW? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
3 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, K982243 (Canogen International, Ltd., 1998) has gone furthest, with 7 descendants of its own.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K780020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K780020: Generator, Oxygen, Portable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K780020
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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