510(k) · Cleared
ClearedTotal O2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chad Therapeutics, Inc. · CAW Generator, Oxygen, Portable
Cleared on Nov 28, 2001 as substantially equivalent to K971889 (Chad Therapeutics, Inc., 1997) after a 41-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.
- Decided
- Nov 28, 2001
- Review
- 41 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971889 (1997). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK971889 Chad Total O2 Delivery SystemChad Therapeutics, Inc. · 1997
- This deviceK013472 Total O2Chad Therapeutics, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK053240 Devilbiss Oxygen Cylinder Filling System, 535 SeriesSunrise Medical · 2006 · Recalled
- 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
- Descendant · cites it directly · 0 of its ownK091028 Omni 5 Total O2 Delivery SystemRespironics, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K053240Devilbiss Oxygen Cylinder Filling System, 535 SeriesSunrise Medical · 2006 · cites it directly2descendants
- K091191Gas TransfillRespironics Inc., Sleep & Home Respiratory Group · 2009 · cites it directly1descendant
- K141967Purefill Oxygen CompressorInovo, Inc. · 2014 · 2 generations on0descendants
- K091028Omni 5 Total O2 Delivery SystemRespironics, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971889 | Chad Total O2 Delivery System | Chad Therapeutics, Inc. | 1997 | — |
| 0 (this device) | K013472 | Total O2 | Chad Therapeutics, Inc. | 2001 | — |
| +1 | K053240 | Devilbiss Oxygen Cylinder Filling System, 535 Series | Sunrise Medical | 2006 | 1 |
| +1 | K091191 | Gas Transfill | Respironics Inc., Sleep & Home Respiratory Group | 2009 | — |
| +2 | K141967 | Purefill Oxygen Compressor | Inovo, Inc. | 2014 | 1 |
| +1 | K091028 | Omni 5 Total O2 Delivery System | Respironics, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 2 | 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? (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 |
|---|---|---|---|
| * | K971889 | Chad Total O2 Delivery SystemSummary page 1…dicate Device Equivalence: Substantial equivalence is claimed to the Chad Therapeutics Unmodified Chad Total O, Delivery System, cleared for commercial distribution per K971889. Device Description: The Chad Total O Delivery System addresses several needs of patients and homecare providers… | 1997 |
What descends from it? (4)
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?
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 modified Chad Total O,™ Delivery System is intended for use in the same manner as the unmodified device:
The Total O,™ Delivery System is indicated for Supplemental Medical Oxygen for treatment of Respiratory Diseases.
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/K013472 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013472: Total O2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013472
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026