510(k) · Cleared
ClearedInovo, Inc, Economizer 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 15, 2003 as substantially equivalent to K010747 (Western Ent., 2001) and 1 other predicate after an 81-day review. Its family tree reaches back 2 generations to 1996. 4 later devices descend from it.
- Decided
- Sep 15, 2003
- Review
- 81 days
- Class
- Class II
- Product code
- NFB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K963247 (1996). 3 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK963247 Victor Model Ocpr Oxygen Conserving Pressure RegulatorThermadyne Holings Corp. · 1996
- 1 generation backK992659 O2N Demand-II, Victor Model Ocpr-IIThermadyne Holings Corp. · 1999
- This deviceK031983 Inovo, Inc, Economizer Conserving RegulatorInovo, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK061785 Cyl-Fil Oxygen SystemResponsive Respiratory, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK080243 Portable Oxygen Unit SCA900San Cheong Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK060751 Inovo, Inc. Accupulse Single Lumen Conserving RegulatorInovo, Inc. · 2006 · Recalled
- Descendant · cites it directly · 0 of its ownK051540 Inovo, Inc. Independence Oxygen Conserving RegulatorInovo, Inc. · 2005
Most influential descendants
Showing 4 of 4 · See all- K061785Cyl-Fil Oxygen SystemResponsive Respiratory, Inc. · 2006 · cites it directly1descendant
- K080243Portable Oxygen Unit SCA900San Cheong Co., Ltd. · 2009 · 2 generations on0descendants
- K060751Inovo, Inc. Accupulse Single Lumen Conserving RegulatorInovo, Inc. · 2006 · cites it directly0descendants
- K051540Inovo, Inc. Independence Oxygen Conserving RegulatorInovo, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963247 | Victor Model Ocpr Oxygen Conserving Pressure Regulator | Thermadyne Holings Corp. | 1996 | — |
| −1 | K992659 | O2N Demand-II, Victor Model Ocpr-II | Thermadyne Holings Corp. | 1999 | — |
| 0 (this device) | K031983 | Inovo, Inc, Economizer Conserving Regulator | Inovo, Inc. | 2003 | — |
| +1 | K061785 | Cyl-Fil Oxygen System | Responsive Respiratory, Inc. | 2006 | — |
| +2 | K080243 | Portable Oxygen Unit SCA900 | San Cheong Co., Ltd. | 2009 | — |
| +1 | K060751 | Inovo, Inc. Accupulse Single Lumen Conserving Regulator | Inovo, Inc. | 2006 | 1 |
| +1 | K051540 | Inovo, Inc. Independence Oxygen Conserving Regulator | Inovo, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K010747 | Opc Oxygen Conserving Regulator, Model Ahg 1968, Lin-7005, MDL-7609, Mem-7612, Opc-830Summary page 1…oy Genc? raI Manager 2. Name of the Device: Inovo, Inc. Economizer Conserving Regulator 3. Predicate Device Information: 1. K#010747, OPC Oxygen Conserving Regulator, Model AHG, Western Medica, West Lake, Ohio 2. K#992659, 02n Demand II, Victor M… | 2001 |
| * | K992659 | O2N Demand-II, Victor Model Ocpr-IISummary page 1…rving Regulator 3. Predicate Device Information: 1. K#010747, OPC Oxygen Conserving Regulator, Model AHG, Western Medica, West Lake, Ohio 2. K#992659, 02n Demand II, Victor Model OCPR-II, and Oxygen Conserving Pressure Regulator-ll (OCPR-II) Victor Equipment Company, De… | 1999 |
| † | K961150 | Dual Lumen Oxygen Delivery Gas Sampling Cannula | 1996 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K061785 (Responsive Respiratory, Inc., 2006) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K010747.
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 Economizer Conserving Regulator is used to deliver a prescribed flow of gas to the patient while conserving gas, 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/K031983 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031983: Inovo, Inc, Economizer 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/K031983
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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