510(k) · Cleared
ClearedPneumatic Demand Oxygen Conserver (Pdoc)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Salter Labs · NFB Conserver, Oxygen
Cleared on May 7, 1999 after a 66-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 7, 1999
- Review
- 66 days
- Class
- Class II
- Product code
- NFB
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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 Salter Labs Pneumatic Demand Oxygen Conserver (PDOC) is indicated for all respiratory or physiological problems where the requirement for supplemental oxygen therapy is indicated by a qualified physician or registered healthcare professional. The PDOC is indicated for use in both the hospital and home care environment where a demand oxygen delivery system is indicated. The PDOC allows for the effective administration of high pressure medical grade or…
Read the full statement (105 words)
The Salter Labs Pneumatic Demand Oxygen Conserver (PDOC) is indicated for all respiratory or physiological problems where the requirement for supplemental oxygen therapy is indicated by a qualified physician or registered healthcare professional. The PDOC is indicated for use in both the hospital and home care environment where a demand oxygen delivery system is indicated.
The PDOC allows for the effective administration of high pressure medical grade or concentrated oxygen upon demand to a patient who has been diagnosed as requiring and which has been prescribed oxygen administration by a physician. Oxygen is administered only during the inhalation cycle, conserving oxygen during the exhalation cycle.
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/K990678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990678: Pneumatic Demand Oxygen Conserver (Pdoc).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990678
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026