510(k) · Cleared
ClearedRugged Oxygen Generator (ROG) (RO01-00001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Molecular Products, Ltd. · CAW Generator, Oxygen, Portable
Cleared on Dec 6, 2024 as substantially equivalent to K131016 (Molecular Products, Ltd., 2013) after a 281-day review. Its family tree reaches back 5 generations to 1978.
- Decided
- Dec 6, 2024
- Review
- 281 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K780020 (1978). No later device cites it as a predicate yet.
- Root · 5 generations backK780020 Generator, Oxygen, PortableJet Research Center, Inc. · 1978
- 4 generations backK982243 Canogen Portable Oxygen Generator Model 615Canogen International, Ltd. · 1998
- 3 generations backK052396 Oxysure Portable Oxygen Generator, Model 615Oxysure Systems, Inc. · 2005 · Recalled
- 2 generations backK062153 Portable Oxygen Generator SystemMolecular Products, Ltd. · 2006
- 1 generation backK131016 ROGSMolecular Products, Ltd. · 2013
- This deviceK240561 Rugged Oxygen Generator (ROG) (RO01-00001)Molecular Products, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K780020 | Generator, Oxygen, Portable | Jet Research Center, Inc. | 1978 | — |
| −4 | K982243 | Canogen Portable Oxygen Generator Model 615 | Canogen International, Ltd. | 1998 | — |
| −3 | K052396 | Oxysure Portable Oxygen Generator, Model 615 | Oxysure Systems, Inc. | 2005 | 1 |
| −2 | K062153 | Portable Oxygen Generator System | Molecular Products, Ltd. | 2006 | — |
| −1 | K131016 | ROGS | Molecular Products, Ltd. | 2013 | — |
| 0 (this device) | K240561 | Rugged Oxygen Generator (ROG) (RO01-00001) | Molecular Products, Ltd. | 2024 | — |
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 |
|---|---|---|---|
| * | K131016 | ROGSSummary page 4…, Oxygen, Portable Product Code: CAW Regulation Number: 21 CFR 868.5440 Predicate Device: ROGS – K131016 Proprietary or Trade Name: Rugged Oxygen Generator (ROG) Common/Usual Name: Oxygen Generator… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 46 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
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?
Intended to produce oxygen for emergency use at 6 LPM flow rate for at least 15 minutes (90 liters) for individuals 17 years and older requiring emergency or supplemental oxygen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240561: Rugged Oxygen Generator (ROG) (RO01-00001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240561
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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