510(k) · Cleared
Recalled · Class II · 2015Oxysure Portable Oxygen Generator, Model 615
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxysure Systems, Inc. · CAW Generator, Oxygen, Portable
Cleared on Dec 9, 2005 as substantially equivalent to K982243 (Canogen International, Ltd., 1998) after a 100-day review. Its family tree reaches back 2 generations to 1978. 5 later devices descend from it. It has been recalled once.
- Decided
- Dec 9, 2005
- Review
- 100 days
- Class
- Class II
- Product code
- CAW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K780020 (1978). 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK780020 Generator, Oxygen, PortableJet Research Center, Inc. · 1978
- 1 generation backK982243 Canogen Portable Oxygen Generator Model 615Canogen International, Ltd. · 1998
- This deviceK052396 Oxysure Portable Oxygen Generator, Model 615Oxysure Systems, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK062153 Portable Oxygen Generator SystemMolecular Products, Ltd. · 2006
- Descendant · 2 generations on · 1 of its ownK131016 ROGSMolecular Products, Ltd. · 2013
- Descendant · 3 generations on · 0 of its ownK240561 Rugged Oxygen Generator (ROG) (RO01-00001)Molecular Products, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK120566 O2PAK Oxygen GeneratorPacific Precision Products · 2012
- Descendant · cites it directly · 0 of its ownK102750 O2-in-a-Box, O2-in-a-BoxGeto2, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K062153Portable Oxygen Generator SystemMolecular Products, Ltd. · 2006 · cites it directly2descendants
- K131016ROGSMolecular Products, Ltd. · 2013 · 2 generations on1descendant
- K240561Rugged Oxygen Generator (ROG) (RO01-00001)Molecular Products, Ltd. · 2024 · 3 generations on0descendants
- K120566O2PAK Oxygen GeneratorPacific Precision Products · 2012 · cites it directly0descendants
- K102750O2-in-a-Box, O2-in-a-BoxGeto2, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K780020 | Generator, Oxygen, Portable | Jet Research Center, Inc. | 1978 | — |
| −1 | K982243 | Canogen Portable Oxygen Generator Model 615 | Canogen International, Ltd. | 1998 | — |
| 0 (this device) | K052396 | Oxysure Portable Oxygen Generator, Model 615 | Oxysure Systems, Inc. | 2005 | — |
| +1 | K062153 | Portable Oxygen Generator System | Molecular Products, Ltd. | 2006 | — |
| +2 | K131016 | ROGS | Molecular Products, Ltd. | 2013 | — |
| +3 | K240561 | Rugged Oxygen Generator (ROG) (RO01-00001) | Molecular Products, Ltd. | 2024 | — |
| +1 | K120566 | O2PAK Oxygen Generator | Pacific Precision Products | 2012 | — |
| +1 | K102750 | O2-in-a-Box, O2-in-a-Box | Geto2, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K982243 | Canogen Portable Oxygen Generator Model 615Summary page 1…Canogen International, Ltd. Syosset, New York 510(k) Number: K982243 Device Description: The OxySure TM System creates medically pure [USP] oxygen at an average flow rate of 6.5 liter… | 1998 |
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 12, 2015 | Class II | Z-2253-2015 | Under Investigation by firm | Flow rate of the recalled replacement cartridges does not meet the draft FDA standard of a minimum 6 LPM for a minimum of 15 minutes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 20.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K062153 (Molecular Products, Ltd., 2006) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K982243.
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 OxySure TM System is intended to produce oxygen for emergency use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052396: Oxysure Portable Oxygen Generator, Model 615.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052396
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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