510(k) · Cleared
Recalled · 2005Modification to Chad Therapeutics Oxymatic Model 401
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 Dec 6, 2000 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it. It has been recalled once.
- Decided
- Dec 6, 2000
- Review
- 29 days
- Class
- Class II
- Product code
- NFB
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK003455 Modification to Chad Therapeutics Oxymatic Model 401Chad Therapeutics, Inc. · 2000
- Descendant · cites it directly · 3 of its ownK042142 Chad Therapeutics Lotus, Models OM-700 and OM-700SChad Therapeutics, Inc. · 2004
- Descendant · 2 generations on · 2 of its ownK103392 Chad Therapeutic Evolution Electronic Oxygen ConserverInovo, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK033364 Chad Therapeutics SageChad Therapeutics, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK113111 Chad Therapeutic Evolution Electronic Oxygen Conserver with MotionInovo, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK220591 ProximaDynasthetics, LLC · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K042142Chad Therapeutics Lotus, Models OM-700 and OM-700SChad Therapeutics, Inc. · 2004 · cites it directly3descendants
- K103392Chad Therapeutic Evolution Electronic Oxygen ConserverInovo, Inc. · 2010 · 2 generations on2descendants
- K033364Chad Therapeutics SageChad Therapeutics, Inc. · 2004 · cites it directly2descendants
- K113111Chad Therapeutic Evolution Electronic Oxygen Conserver with MotionInovo, Inc. · 2011 · 2 generations on1descendant
- K220591ProximaDynasthetics, LLC · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003455 | Modification to Chad Therapeutics Oxymatic Model 401 | Chad Therapeutics, Inc. | 2000 | — |
| +1 | K042142 | Chad Therapeutics Lotus, Models OM-700 and OM-700S | Chad Therapeutics, Inc. | 2004 | — |
| +2 | K103392 | Chad Therapeutic Evolution Electronic Oxygen Conserver | Inovo, Inc. | 2010 | — |
| +1 | K033364 | Chad Therapeutics Sage | Chad Therapeutics, Inc. | 2004 | — |
| +2 | K113111 | Chad Therapeutic Evolution Electronic Oxygen Conserver with Motion | Inovo, Inc. | 2011 | — |
| +3 | K220591 | Proxima | Dynasthetics, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 25, 2005 | Not classified | Z-1068-05 | Other | "Shot size" below manufacturing specifications. Risk of less than the specified quantity of oxygen delivered per pulse. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042142 (Chad Therapeutics, Inc., 2004) has gone furthest, with 3 descendants 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 | — |
https://510kreport.com/device/K003455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003455: Modification to Chad Therapeutics Oxymatic Model 401.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003455
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026