510(k) · Cleared
ClearedDemand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Salter Labs · NFB Conserver, Oxygen
Cleared on Mar 11, 2016 as substantially equivalent to K890298 (Salter Labs, 1989) and 1 other predicate after a 281-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Mar 11, 2016
- Review
- 281 days
- Class
- Class II
- Product code
- NFB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K890298 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK890298 Demand Nasal Oxygen Cannula Models 4008/4108/4208Salter Labs · 1989
- This deviceK151506 Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaSalter Labs · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890298 | Demand Nasal Oxygen Cannula Models 4008/4108/4208 | Salter Labs | 1989 | — |
| 0 (this device) | K151506 | Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula | Salter Labs | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 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 |
|---|---|---|---|
| * | K890298 | Demand Nasal Oxygen Cannula Models 4008/4108/4208Summary page 4…: 868.5905 Classification: I Classification Panel: Anaesthesiology C. Predicate Devices: This submission demonstrates substantial equivalence to the predicate devices: K890298, Demand Nasal Oxygen Cannula K892407, Modified Demand Nasal Oxygen Cannula Page 50 of 58 Page 050 of 161 Device… | 1989 |
| * | K892407 | Modified Demand Nasal Oxygen CannulaSummary page 4…ication Panel: Anaesthesiology C. Predicate Devices: This submission demonstrates substantial equivalence to the predicate devices: K890298, Demand Nasal Oxygen Cannula K892407, Modified Demand Nasal Oxygen Cannula Page 50 of 58 Page 050 of 161 Device Descriptions The demand cannula is a… | 1989 |
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.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All NFB devicesNFB Conserver, Oxygen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 intended use is to deliver oxygen to the patient nasally, controlled by a demand system
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/K151506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151506: Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151506
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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