510(k) · Cleared
ClearedCanogen Portable Oxygen Generator Model 615
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canogen International, Ltd. · CAW Generator, Oxygen, Portable
Cleared on Nov 19, 1998 as substantially equivalent to K780020 (Jet Research Center, Inc., 1978) after a 147-day review. Its family tree reaches back 1 generation to 1978. 7 later devices descend from it.
- Decided
- Nov 19, 1998
- Review
- 147 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K780020 (1978). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK780020 Generator, Oxygen, PortableJet Research Center, Inc. · 1978
- This deviceK982243 Canogen Portable Oxygen Generator Model 615Canogen International, Ltd. · 1998
- Descendant · cites it directly · 5 of its ownK052396 Oxysure Portable Oxygen Generator, Model 615Oxysure Systems, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 2 of its ownK062153 Portable Oxygen Generator SystemMolecular Products, Ltd. · 2006
- Descendant · 3 generations on · 1 of its ownK131016 ROGSMolecular Products, Ltd. · 2013
- Descendant · 4 generations on · 0 of its ownK240561 Rugged Oxygen Generator (ROG) (RO01-00001)Molecular Products, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK120566 O2PAK Oxygen GeneratorPacific Precision Products · 2012
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K052396Oxysure Portable Oxygen Generator, Model 615Oxysure Systems, Inc. · 2005 · cites it directly5descendants
- K062153Portable Oxygen Generator SystemMolecular Products, Ltd. · 2006 · 2 generations on2descendants
- K131016ROGSMolecular Products, Ltd. · 2013 · 3 generations on1descendant
- K240561Rugged Oxygen Generator (ROG) (RO01-00001)Molecular Products, Ltd. · 2024 · 4 generations on0descendants
- K120566O2PAK Oxygen GeneratorPacific Precision Products · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K780020 | Generator, Oxygen, Portable | Jet Research Center, Inc. | 1978 | — |
| 0 (this device) | K982243 | Canogen Portable Oxygen Generator Model 615 | Canogen International, Ltd. | 1998 | — |
| +1 | K052396 | Oxysure Portable Oxygen Generator, Model 615 | Oxysure Systems, Inc. | 2005 | 1 |
| +2 | K062153 | Portable Oxygen Generator System | Molecular Products, Ltd. | 2006 | — |
| +3 | K131016 | ROGS | Molecular Products, Ltd. | 2013 | — |
| +4 | K240561 | Rugged Oxygen Generator (ROG) (RO01-00001) | Molecular Products, Ltd. | 2024 | — |
| +2 | K120566 | O2PAK Oxygen Generator | Pacific Precision Products | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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.
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? (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 |
|---|---|---|---|
| * | K780020 | Generator, Oxygen, PortableSummary page 1…e Oxygen Generator Classification Name: Portable Oxygen Generator C. Predicate Device: Jet Research Center, Model 415 Oxygen Canister and Dispenser Model 3445-c, 510(k) #K780020 D. Device Description: The Canogen Portable Oxygen Generator. Model 615 provides an average of 6.5 liters a minute for a mimimum… | 1978 |
What descends from it? (7)
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?
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 | — |
What is it indicated for?
The Canogen Portable Oxygen Generator, Model 615 is intended to produce oxygen for emergency use.
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/K982243 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982243: Canogen Portable Oxygen Generator Model 615.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982243
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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