510(k) · Cleared
ClearedInogen Satellite Conserver, Model SC-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Electronic Devices, Inc. · NFB Conserver, Oxygen
Cleared on Oct 24, 2005 as substantially equivalent to K033197 (Medical Electronic Devices, Inc., 2004) and 2 other predicates after a 35-day review. Its family tree reaches back 4 generations to 1985.
- Decided
- Oct 24, 2005
- Review
- 35 days
- Class
- Class II
- Product code
- NFB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K852650 (1985). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK852650 Oxymatictm Electronic Oxgyen ConserverChad Therapeutics, Inc. · 1985
- 3 generations backK983459 Pulsed Oxygen Conserving Device, PocdMedical Electronic Devices, Inc. · 1998
- 2 generations backK023420 Pulsed Oxygen Conserving Device - Every Breath, Pocdeb, ReactebMedical Electronic Devices, Inc. · 2002
- 1 generation backK033197 Inogen Satellite ConserverMedical Electronic Devices, Inc. · 2004
- This deviceK052563 Inogen Satellite Conserver, Model SC-100Medical Electronic Devices, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K852650 | Oxymatictm Electronic Oxgyen Conserver | Chad Therapeutics, Inc. | 1985 | — |
| −3 | K983459 | Pulsed Oxygen Conserving Device, Pocd | Medical Electronic Devices, Inc. | 1998 | — |
| −2 | K023420 | Pulsed Oxygen Conserving Device - Every Breath, Pocdeb, Reacteb | Medical Electronic Devices, Inc. | 2002 | — |
| −1 | K033197 | Inogen Satellite Conserver | Medical Electronic Devices, Inc. | 2004 | — |
| 0 (this device) | K052563 | Inogen Satellite Conserver, Model SC-100 | Medical Electronic Devices, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 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? (3)
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 |
|---|---|---|---|
| * | K033197 | Inogen Satellite ConserverSummary page 1…ification Name: Non Continuous Ventilator (IPPB) Predicate Device Equivalence: Substantial equivalence is claimed to the Inogen Satellite Conserver SC-l00 (K033197), CHAD Therapeutics Oxymatic Model 411 (K003455), and Invacare Venture IDD Oxygen Conserving Device (K002284). Device Descriptio… | 2004 |
| * | K003455 | Modification to Chad Therapeutics Oxymatic Model 401Summary page 1…ilator (IPPB) Predicate Device Equivalence: Substantial equivalence is claimed to the Inogen Satellite Conserver SC-l00 (K033197), CHAD Therapeutics Oxymatic Model 411 (K003455), and Invacare Venture IDD Oxygen Conserving Device (K002284). Device Description: The Inogen Satellite Conserver is a battery o… | 2000 |
| * | K002284 | Venture Idd Oxygen Conserving Device Idd 20EX and 50EXSummary page 1…valence is claimed to the Inogen Satellite Conserver SC-l00 (K033197), CHAD Therapeutics Oxymatic Model 411 (K003455), and Invacare Venture IDD Oxygen Conserving Device (K002284). Device Description: The Inogen Satellite Conserver is a battery operated electronic device that is microprocessor controlled a… | 2000 |
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 20 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 9 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.
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?
Intended for use to conserve oxygen for patients prescribed supplemental oxygen and use nasal cannulas as part of an oxygen delivery system including an oxygen concentrator, compressed oxygen cylinder, or liquid-oxygen system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052563 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052563: Inogen Satellite Conserver, Model SC-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052563
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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