510(k) · Cleared
ClearedPulse Dose Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Devilbiss Health Care, Inc. · NFB Conserver, Oxygen
Cleared on Oct 21, 1996 after a 214-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Oct 21, 1996
- Review
- 214 days
- Class
- Class II
- Product code
- NFB
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK961126 Pulse Dose SeriesDevilbiss Health Care, Inc. · 1996
- Descendant · cites it directly · 5 of its ownK020329 Devilbiss PD1000Sunrise Medical Hhg, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 2 of its ownK090421 Model 350G Gas ConserverInspired Technologies, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK033364 Chad Therapeutics SageChad Therapeutics, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK113111 Chad Therapeutic Evolution Electronic Oxygen Conserver with MotionInovo, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK220591 ProximaDynasthetics, LLC · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K020329Devilbiss PD1000Sunrise Medical Hhg, Inc. · 2002 · cites it directly5descendants
- K090421Model 350G Gas ConserverInspired Technologies, Inc. · 2009 · 2 generations on2descendants
- K033364Chad Therapeutics SageChad Therapeutics, Inc. · 2004 · cites it directly2descendants
- K113111Chad Therapeutic Evolution Electronic Oxygen Conserver with MotionInovo, Inc. · 2011 · 2 generations on1descendant
- K220591ProximaDynasthetics, LLC · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961126 | Pulse Dose Series | Devilbiss Health Care, Inc. | 1996 | — |
| +1 | K020329 | Devilbiss PD1000 | Sunrise Medical Hhg, Inc. | 2002 | 2 |
| +2 | K090421 | Model 350G Gas Conserver | Inspired Technologies, Inc. | 2009 | — |
| +1 | K033364 | Chad Therapeutics Sage | Chad Therapeutics, Inc. | 2004 | — |
| +2 | K113111 | Chad Therapeutic Evolution Electronic Oxygen Conserver with Motion | Inovo, Inc. | 2011 | — |
| +3 | K220591 | Proxima | Dynasthetics, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | — | OMS 20 Named without a submission number | |
| * | — | OMS 50 Named without a submission number |
What descends from it? (9)
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?
- Of its descendants, K020329 (Sunrise Medical Hhg, Inc., 2002) has gone furthest, with 5 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 devices provide a bolus of oxygen to a patient at the start of inhalation. The devices assist patients, who require prescribed doses of supplemental gases such as oxygen, to conserve gas from the various gaseous cylinders or liquid oxygen reservoirs. By allowing oxygen to flow only from the cylinder or liquid oxygen reservoirs during the inspiratory segment of a patient's breathing cycle, conservation occurs.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961126: Pulse Dose Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961126
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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