510(k) · Cleared
ClearedChad Total O2 Delivery System
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 17, 1997 after a 180-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Nov 17, 1997
- Review
- 180 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK971889 Chad Total O2 Delivery SystemChad Therapeutics, Inc. · 1997
- Descendant · cites it directly · 4 of its ownK013472 Total O2Chad Therapeutics, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK053240 Devilbiss Oxygen Cylinder Filling System, 535 SeriesSunrise Medical · 2006 · Recalled
- Descendant · 2 generations on · 1 of its ownK091191 Gas TransfillRespironics Inc., Sleep & Home Respiratory Group · 2009
- Descendant · 3 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K013472Total O2Chad Therapeutics, Inc. · 2001 · cites it directly4descendants
- K053240Devilbiss Oxygen Cylinder Filling System, 535 SeriesSunrise Medical · 2006 · cites it directly2descendants
- K091191Gas TransfillRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on1descendant
- K141967Purefill Oxygen CompressorInovo, Inc. · 2014 · 3 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 |
|---|---|---|---|---|---|
| 0 (this device) | K971889 | Chad Total O2 Delivery System | Chad Therapeutics, Inc. | 1997 | — |
| +1 | K013472 | Total O2 | Chad Therapeutics, Inc. | 2001 | — |
| +1 | K053240 | Devilbiss Oxygen Cylinder Filling System, 535 Series | Sunrise Medical | 2006 | 1 |
| +2 | K091191 | Gas Transfill | Respironics Inc., Sleep & Home Respiratory Group | 2009 | — |
| +3 | 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 |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
4 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?
- Of its descendants, K013472 (Chad Therapeutics, Inc., 2001) has gone furthest, with 4 descendants of its own.
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 TOTAL O2™ Delivery System is indicated for Supplemental Medical Oxygen for treatment of Respiratory Diseases.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971889 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971889: Chad Total O2 Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971889
Report an extraction error
Are you the manufacturer?
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