510(k) · Cleared
ClearedChad Therapeutics Sage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chad Therapeutics, Inc. · NFB Conserver, Oxygen
Cleared on May 11, 2004 as substantially equivalent to K000890 (Chad Therapeutics, Inc., 2000) and 3 other predicates after a 203-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- May 11, 2004
- Review
- 203 days
- Class
- Class II
- Product code
- NFB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K961126 (1996). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK961126 Pulse Dose SeriesDevilbiss Health Care, Inc. · 1996
- This deviceK033364 Chad Therapeutics SageChad Therapeutics, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK113111 Chad Therapeutic Evolution Electronic Oxygen Conserver with MotionInovo, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK220591 ProximaDynasthetics, LLC · 2022
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 |
|---|---|---|---|---|---|
| −1 | K961126 | Pulse Dose Series | Devilbiss Health Care, Inc. | 1996 | — |
| 0 (this device) | K033364 | Chad Therapeutics Sage | Chad Therapeutics, Inc. | 2004 | — |
| +1 | K113111 | Chad Therapeutic Evolution Electronic Oxygen Conserver with Motion | Inovo, Inc. | 2011 | — |
| +2 | K220591 | Proxima | Dynasthetics, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2022 | 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 NFB? 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 NFB device
- #1 K250322 Respond OC Conserving Regulator (130-0800)score 10.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K000890 | Chad Therapeutics Oxymatic Model 401Summary page 1…Device Equivalence: Substantial equivalence is claimed to the Chad Therapeutics 400 Series conservers cleared for commercial distribution per K000890, K003455, K01 0389 and the DeVilbiss PulseDose conserving device cleared for commercial distribution pe… | 2000 |
| * | K003455 | Modification to Chad Therapeutics Oxymatic Model 401Summary page 1…quivalence: Substantial equivalence is claimed to the Chad Therapeutics 400 Series conservers cleared for commercial distribution per K000890, K003455, K01 0389 and the DeVilbiss PulseDose conserving device cleared for commercial distribution per K961 12… | 2000 |
| * | K010389 | Chad Therapeutics Oxymatic Model 401 and Oxymatic Model 411Summary page 1…e: Substantial equivalence is claimed to the Chad Therapeutics 400 Series conservers cleared for commercial distribution per K000890, K003455, K01 0389 and the DeVilbiss PulseDose conserving device cleared for commercial distribution per K961 126.… | 2001 |
| * | K961126 | Pulse Dose SeriesSummary page 1…or commercial distribution per K000890, K003455, K01 0389 and the DeVilbiss PulseDose conserving device cleared for commercial distribution per K961 126. CHAD, OXYMATIC OXYMIZER. OXYLITE AND TOTAL C) ARF RVAEG)ELRD TRADF.MARKS OF CHAD THERAPELJ… | 1996 |
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 |
|---|---|---|---|
| K113111 | Chad Therapeutic Evolution Electronic Oxygen Conserver with Motion | 2011 | 1 |
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?
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K113111 (Inovo, Inc., 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NFB devicesNFB Conserver, Oxygen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NFB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NFB
Too few NFB 510(k)s in any year since 2007 to give a median.
Recalls per year · NFB
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NFB
8in 2025
MAUDE reports naming product code NFB, 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 | 1 | — | 3 | 3 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Chad Therapeutics Sage is intended for prescription use only, to be used as part of a portable therapeutic oxygen system for patients that require supplemental oxygen while at rest or during activity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033364 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033364: Chad Therapeutics Sage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033364
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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