510(k) · Cleared
ClearedChad Therapeutics Lotus, Models OM-700 and OM-700S
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 Sep 20, 2004 as substantially equivalent to K003455 (Chad Therapeutics, Inc., 2000) after a 42-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.
- Decided
- Sep 20, 2004
- Review
- 42 days
- Class
- Class II
- Product code
- NFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003455 (2000). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK003455 Modification to Chad Therapeutics Oxymatic Model 401Chad Therapeutics, Inc. · 2000 · Recalled
- This deviceK042142 Chad Therapeutics Lotus, Models OM-700 and OM-700SChad Therapeutics, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK103392 Chad Therapeutic Evolution Electronic Oxygen ConserverInovo, Inc. · 2010
- 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
Most influential descendants
Showing 3 of 3 · See all- K103392Chad Therapeutic Evolution Electronic Oxygen ConserverInovo, Inc. · 2010 · 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 |
|---|---|---|---|---|---|
| −1 | K003455 | Modification to Chad Therapeutics Oxymatic Model 401 | Chad Therapeutics, Inc. | 2000 | 1 |
| 0 (this device) | K042142 | Chad Therapeutics Lotus, Models OM-700 and OM-700S | Chad Therapeutics, Inc. | 2004 | — |
| +1 | K103392 | Chad Therapeutic Evolution Electronic Oxygen Conserver | Inovo, Inc. | 2010 | — |
| +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 |
|---|---|---|
| 2010 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K003455 | Modification to Chad Therapeutics Oxymatic Model 401Summary page 1…Equivalence: Substantial equivalence is claimed to the Chad Therapeutics Unmodified OXYMATIC 411, cleared for commercial distribution per K003455. III CHAD T[ILHEAR11II.… | 2000 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103392 | Chad Therapeutic Evolution Electronic Oxygen Conserver | 2010 | 2 |
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 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 Lotus (modified Chad Therapeutics OXYMATIC Model 411) is intended for use in the same manner as the unmodified device, i.e., for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen up to 6 liters per minute, in their home and for ambulatory use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042142 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042142: Chad Therapeutics Lotus, Models OM-700 and OM-700S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042142
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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