510(k) · Cleared
ClearedO2N Demand-II, Victor Model Ocpr-II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermadyne Holings Corp. · NFB Conserver, Oxygen
Cleared on Sep 3, 1999 as substantially equivalent to K963247 (Thermadyne Holings Corp., 1996) after a 25-day review. Its family tree reaches back 1 generation to 1996. 8 later devices descend from it.
- Decided
- Sep 3, 1999
- Review
- 25 days
- Class
- Class II
- Product code
- NFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963247 (1996). 8 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK963247 Victor Model Ocpr Oxygen Conserving Pressure RegulatorThermadyne Holings Corp. · 1996
- This deviceK992659 O2N Demand-II, Victor Model Ocpr-IIThermadyne Holings Corp. · 1999
- Descendant · cites it directly · 4 of its ownK031983 Inovo, Inc, Economizer Conserving RegulatorInovo, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK020475 Chad Therapeutics Oxypenumatic Cypress Model 511Chad Therapeutics, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK070740 Chad Therapeutics Bonsai Model 800Chad Therapeutics, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK061785 Cyl-Fil Oxygen SystemResponsive Respiratory, Inc. · 2006
- Descendant · 3 generations on · 0 of its ownK250322 Respond OC Conserving Regulator (130-0800)Responsive Respiratory · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K031983Inovo, Inc, Economizer Conserving RegulatorInovo, Inc. · 2003 · cites it directly4descendants
- K020475Chad Therapeutics Oxypenumatic Cypress Model 511Chad Therapeutics, Inc. · 2002 · cites it directly3descendants
- K070740Chad Therapeutics Bonsai Model 800Chad Therapeutics, Inc. · 2007 · 2 generations on1descendant
- K061785Cyl-Fil Oxygen SystemResponsive Respiratory, Inc. · 2006 · 2 generations on1descendant
- K250322Respond OC Conserving Regulator (130-0800)Responsive Respiratory · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963247 | Victor Model Ocpr Oxygen Conserving Pressure Regulator | Thermadyne Holings Corp. | 1996 | — |
| 0 (this device) | K992659 | O2N Demand-II, Victor Model Ocpr-II | Thermadyne Holings Corp. | 1999 | — |
| +1 | K031983 | Inovo, Inc, Economizer Conserving Regulator | Inovo, Inc. | 2003 | — |
| +1 | K020475 | Chad Therapeutics Oxypenumatic Cypress Model 511 | Chad Therapeutics, Inc. | 2002 | — |
| +2 | K070740 | Chad Therapeutics Bonsai Model 800 | Chad Therapeutics, Inc. | 2007 | — |
| +2 | K061785 | Cyl-Fil Oxygen System | Responsive Respiratory, Inc. | 2006 | — |
| +3 | K250322 | Respond OC Conserving Regulator (130-0800) | Responsive Respiratory | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 |
|---|---|---|---|
| * | K963247 | Victor Model Ocpr Oxygen Conserving Pressure RegulatorSummary page 3…ations For Use: The 02n Demand-II is intended as an ‘oxygen consexrving pressure regulator for ambulatory patients. This is the same intended use as the predicated unit (K963247). r(fé.ggge DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF D) , Concutrence of CDRH, Office of Devics Evaluation (ODE… | 1996 |
What descends from it? (8)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K031983 (Inovo, Inc., 2003) has gone furthest, with 4 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.
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 02n Demand-II is intended as an ‘oxygen conserving pressure regulator for ambulatory patients. This is the same intended use as the predicated unit (K963247).
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992659 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992659: O2N Demand-II, Victor Model Ocpr-II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992659
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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