510(k) · Cleared
Recalled · 2007Devilbiss PD1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise Medical Hhg, Inc. · NFB Conserver, Oxygen
Cleared on Jun 19, 2002 as substantially equivalent to K961126 (Devilbiss Health Care, Inc., 1996) after a 139-day review. Its family tree reaches back 1 generation to 1996. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 19, 2002
- Review
- 139 days
- Class
- Class II
- Product code
- NFB
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961126 (1996). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK961126 Pulse Dose SeriesDevilbiss Health Care, Inc. · 1996
- This deviceK020329 Devilbiss PD1000Sunrise Medical Hhg, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK090421 Model 350G Gas ConserverInspired Technologies, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK221014 Effortless Oxygen Conserver System Models Effortless Pro and…Effortless Oxygen, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK200401 ApogeeIncoba Ltd D/B/A Dynaris · 2020
- Descendant · cites it directly · 0 of its ownK051540 Inovo, Inc. Independence Oxygen Conserving RegulatorInovo, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK041568 EOCDRespironics, Inc. · 2004
Most influential descendants
Showing 5 of 5 · See all- K090421Model 350G Gas ConserverInspired Technologies, Inc. · 2009 · cites it directly2descendants
- K221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLC · 2022 · 2 generations on0descendants
- K200401ApogeeIncoba Ltd D/B/A Dynaris · 2020 · 2 generations on0descendants
- K051540Inovo, Inc. Independence Oxygen Conserving RegulatorInovo, Inc. · 2005 · cites it directly0descendants
- K041568EOCDRespironics, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961126 | Pulse Dose Series | Devilbiss Health Care, Inc. | 1996 | — |
| 0 (this device) | K020329 | Devilbiss PD1000 | Sunrise Medical Hhg, Inc. | 2002 | — |
| +1 | K090421 | Model 350G Gas Conserver | Inspired Technologies, Inc. | 2009 | — |
| +2 | K221014 | Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile | Effortless Oxygen, LLC | 2022 | — |
| +2 | K200401 | Apogee | Incoba Ltd D/B/A Dynaris | 2020 | — |
| +1 | K051540 | Inovo, Inc. Independence Oxygen Conserving Regulator | Inovo, Inc. | 2005 | — |
| +1 | K041568 | EOCD | Respironics, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K961126 | Pulse Dose SeriesSummary page 1…ice to which Equivalence is Claimed: DeVilbiss EX2000 Pulse Dose Manufacturer: Sunrise Medical HHG, Inc. Respiratory Products Division Predicate Device 5 1O(k) Number: K96 1126 Device Description: The DeVilbiss PDlOOO compact conserving device is designed to extend the use time of oxygen cylinders. Th… | 1996 |
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 24, 2007 | Not classified | Z-0732-2007 | Other | Cylinder could lose oxygen at high pressure after the filling process |
| Jan 24, 2007 | Not classified | Z-0731-2007 | Other | Cylinder could lose oxygen at high pressure after the filling process |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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.DeVilbiss PDlOQO Compact Conserver is intended as a delivery device for medial-grade oxygen from high-pressure oxygen cylinders. This is an ambulatory device, which allows patients to ambulate longer than they would with a continuous flow regulator on the same cylinder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020329: Devilbiss PD1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020329
Report an extraction error
Are you the manufacturer?
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