510(k) · Cleared
ClearedInovo, Inc. Independence Oxygen Conserving Regulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inovo, Inc. · NFB Conserver, Oxygen
Cleared on Sep 21, 2005 as substantially equivalent to K031983 (Inovo, Inc., 2003) and 2 other predicates after a 103-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Sep 21, 2005
- Review
- 103 days
- Class
- Class II
- Product code
- NFB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K963247 (1996). 7 ancestors in all, the oldest K961126 (1996). No later device cites it as a predicate yet.
- Root · 3 generations backK963247 Victor Model Ocpr Oxygen Conserving Pressure RegulatorThermadyne Holings Corp. · 1996
- 2 generations backK992659 O2N Demand-II, Victor Model Ocpr-IIThermadyne Holings Corp. · 1999
- 1 generation backK031983 Inovo, Inc, Economizer Conserving RegulatorInovo, Inc. · 2003
- This deviceK051540 Inovo, Inc. Independence Oxygen Conserving RegulatorInovo, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963247 | Victor Model Ocpr Oxygen Conserving Pressure Regulator | Thermadyne Holings Corp. | 1996 | — |
| −2 | K992659 | O2N Demand-II, Victor Model Ocpr-II | Thermadyne Holings Corp. | 1999 | — |
| −1 | K031983 | Inovo, Inc, Economizer Conserving Regulator | Inovo, Inc. | 2003 | — |
| 0 (this device) | K051540 | Inovo, Inc. Independence Oxygen Conserving Regulator | Inovo, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 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 |
|---|---|---|---|
| * | K031983 | Inovo, Inc, Economizer Conserving RegulatorSummary page 1…ulator 2a. Class and Product Code Class II, Product Code NFB , Anesthesiology Panel 3. Predicate Device Information: 1. Inovo Economizer (K031983) 2. DeVilbiss PDI000 (K020329) 3. Chad Oxymatic (K003455) 4. Device Description: The Inovo… | 2003 |
| * | K020329 | Devilbiss PD1000Summary page 1…Class II, Product Code NFB , Anesthesiology Panel 3. Predicate Device Information: 1. Inovo Economizer (K031983) 2. DeVilbiss PDI000 (K020329) 3. Chad Oxymatic (K003455) 4. Device Description: The Inovo, Inc. Independence Conserving Regulator i… | 2002 |
| * | K003455 | Modification to Chad Therapeutics Oxymatic Model 401Summary page 1…hesiology Panel 3. Predicate Device Information: 1. Inovo Economizer (K031983) 2. DeVilbiss PDI000 (K020329) 3. Chad Oxymatic (K003455) 4. Device Description: The Inovo, Inc. Independence Conserving Regulator is a high pressure oxygen regula… | 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 9 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 7 ancestors have a recall of any class.
- 2 other devices also cite its predicate K031983.
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 Inovo Independence Conserving Regulator is used to deliver a
prescribed flow of medical-grade oxygen to the patient while conserving gas
from a high-pressure oxygen cylinder, by sensing the patient inhalation cycle
and supplying gas only during that phase of breathing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051540 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051540: Inovo, Inc. Independence Oxygen Conserving Regulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051540
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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