510(k) · Cleared
ClearedChad Therapeutic Evolution Electronic Oxygen Conserver with Motion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inovo, Inc. · NFB Conserver, Oxygen
Cleared on Dec 8, 2011 as substantially equivalent to K103392 (Inovo, Inc., 2010) and 1 other predicate after a 49-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Dec 8, 2011
- Review
- 49 days
- Class
- Class II
- Product code
- NFB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K003455 (2000). 7 ancestors in all, the oldest K961126 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK003455 Modification to Chad Therapeutics Oxymatic Model 401Chad Therapeutics, Inc. · 2000 · Recalled
- 2 generations backK042142 Chad Therapeutics Lotus, Models OM-700 and OM-700SChad Therapeutics, Inc. · 2004
- 1 generation backK103392 Chad Therapeutic Evolution Electronic Oxygen ConserverInovo, Inc. · 2010
- This deviceK113111 Chad Therapeutic Evolution Electronic Oxygen Conserver with MotionInovo, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK220591 ProximaDynasthetics, LLC · 2022
Most influential descendants
Showing 1 of 1 · See all- K220591ProximaDynasthetics, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003455 | Modification to Chad Therapeutics Oxymatic Model 401 | Chad Therapeutics, Inc. | 2000 | 1 |
| −2 | 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 | — |
| 0 (this device) | K113111 | Chad Therapeutic Evolution Electronic Oxygen Conserver with Motion | Inovo, Inc. | 2011 | — |
| +1 | K220591 | Proxima | Dynasthetics, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K103392 | Chad Therapeutic Evolution Electronic Oxygen Conserver Our reading of the summary gave K103302, FDA’s number for Stempro MSC SFM (Life Technologies Corporation). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Chad Therapeutic Evolution Model OM-900”. | 2010 |
| * | K033364 | Chad Therapeutics SageSummary page 2…ceased, the software will then revert to the original rest setting(rest mode). The motion technology is taken from a previously cleared device Chad Sage Model TO-i100 - K033364. Intended Use: The Chad Therapeutics Evolution Model OM-900M is intended for prescription use only, to be used as part of a por… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220591 | Proxima | 2022 | 0 |
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K220591 (Dynasthetics, LLC, 2022) has gone furthest, with 0 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. 2011, this device’s year, is highlighted.
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 Evolution Model OM-900M is intended 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K113111 · printed Nov 3, 2026
Cite this page
510(k) Report. “K113111: Chad Therapeutic Evolution Electronic Oxygen Conserver with Motion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113111
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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