510(k) · Cleared
ClearedProxima
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynasthetics, LLC · NFB Conserver, Oxygen
Cleared on Dec 15, 2022 as substantially equivalent to K113111 (Inovo, Inc., 2011) after a 289-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Dec 15, 2022
- Review
- 289 days
- Class
- Class II
- Product code
- NFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003455 (2000). 8 ancestors in all, the oldest K961126 (1996). No later device cites it as a predicate yet.
- Root · 4 generations backK003455 Modification to Chad Therapeutics Oxymatic Model 401Chad Therapeutics, Inc. · 2000 · Recalled
- 3 generations backK042142 Chad Therapeutics Lotus, Models OM-700 and OM-700SChad Therapeutics, Inc. · 2004
- 2 generations backK103392 Chad Therapeutic Evolution Electronic Oxygen ConserverInovo, Inc. · 2010
- 1 generation backK113111 Chad Therapeutic Evolution Electronic Oxygen Conserver with MotionInovo, Inc. · 2011
- This deviceK220591 ProximaDynasthetics, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003455 | Modification to Chad Therapeutics Oxymatic Model 401 | Chad Therapeutics, Inc. | 2000 | 1 |
| −3 | 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 | K113111 | Chad Therapeutic Evolution Electronic Oxygen Conserver with Motion | Inovo, Inc. | 2011 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K113111 | Chad Therapeutic Evolution Electronic Oxygen Conserver with MotionSummary page 4…NFB Classification Name: Conserver, Oxygen Predicate Device: Inovo Evolution Electronic Oxygen Conserver, K113111 Proprietary or Trade Name: Proxima™ Model-100 Smart Supplemental Oxygen System Common/Usual Name:… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
How does its category compare?
All NFB devicesNFB Conserver, Oxygen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Proxima is intended for prescription use only, to be used for adult patients that require supplemental oxygen in a hospital setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220591: Proxima.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220591
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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