510(k) · Cleared
Recalled · 2006Devilbiss Oxygen Cylinder Filling System, 535 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise Medical · CAW Generator, Oxygen, Portable
Cleared on Feb 3, 2006 as substantially equivalent to K013472 (Chad Therapeutics, Inc., 2001) and 1 other predicate after a 77-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it. It has been recalled once.
- Decided
- Feb 3, 2006
- Review
- 77 days
- Class
- Class II
- Product code
- CAW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K971889 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK971889 Chad Total O2 Delivery SystemChad Therapeutics, Inc. · 1997
- 1 generation backK013472 Total O2Chad Therapeutics, Inc. · 2001
- This deviceK053240 Devilbiss Oxygen Cylinder Filling System, 535 SeriesSunrise Medical · 2006
- Descendant · cites it directly · 1 of its ownK091191 Gas TransfillRespironics Inc., Sleep & Home Respiratory Group · 2009
- Descendant · 2 generations on · 0 of its ownK141967 Purefill Oxygen CompressorInovo, Inc. · 2014 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971889 | Chad Total O2 Delivery System | Chad Therapeutics, Inc. | 1997 | — |
| −1 | K013472 | Total O2 | Chad Therapeutics, Inc. | 2001 | — |
| 0 (this device) | K053240 | Devilbiss Oxygen Cylinder Filling System, 535 Series | Sunrise Medical | 2006 | — |
| +1 | K091191 | Gas Transfill | Respironics Inc., Sleep & Home Respiratory Group | 2009 | — |
| +2 | K141967 | Purefill Oxygen Compressor | Inovo, Inc. | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 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? (2)
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 |
|---|---|---|---|
| * | K013472 | Total O2Summary page 1…21 CFR 868.5440 Predicate Device Name(s) and 510(k) CHAD Therapeutics Total 02 number(s): Delivery System (K013472) CHAD Therapeutics Total 02… | 2001 |
| * | K971889 | Chad Total O2 Delivery SystemSummary page 1…y System (K013472) CHAD Therapeutics Total 02 Delivery System (K971889) DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service A… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091191 | Gas Transfill | 2009 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 24, 2006 | Not classified | Z-0038-2007 | Other | Potential for oxygen cylinders to not fill completely |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K091191 (Respironics Inc., Sleep & Home Respiratory Group, 2009) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K013472.
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 Model 535D Oxygen Cylinder Filling System is intended for use in supplying pressurized oxygen to fill oxygen cylinders for patients' ambulatory use. The device is intended to provide 93% (± 3%) oxygen. This device can be used in homes, nursing homes, patient care facilities, etc.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053240 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053240: Devilbiss Oxygen Cylinder Filling System, 535 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053240
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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