510(k) · Cleared
ClearedEasy Pulse II Oxygen Conserver
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Medical, Inc. · NFB Conserver, Oxygen
Cleared on Aug 25, 2003 after a 56-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Aug 25, 2003
- Review
- 56 days
- Class
- Class II
- Product code
- NFB
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK032018 Easy Pulse II Oxygen ConserverPrecision Medical, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK060751 Inovo, Inc. Accupulse Single Lumen Conserving RegulatorInovo, Inc. · 2006 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K060751Inovo, Inc. Accupulse Single Lumen Conserving RegulatorInovo, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032018 | Easy Pulse II Oxygen Conserver | Precision Medical, Inc. | 2003 | — |
| +1 | K060751 | Inovo, Inc. Accupulse Single Lumen Conserving Regulator | Inovo, Inc. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060751 | Inovo, Inc. Accupulse Single Lumen Conserving Regulator | 2006 | 0 |
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, K060751 (Inovo, Inc., 2006) has gone furthest, with 0 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 Precision Medical, Inc. Easy Pulse II Oxygen Conserver is intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. The patients would normally receive the oxygen via a nasal cannula. The system delivers 100% oxygen at 5 different flow settings. It is intended to be used as ambulatory source of oxygen both inside and outside of the patient’s home. It is not intended as a life supporting device. The device has no contraindications.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K032018 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032018: Easy Pulse II Oxygen Conserver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032018
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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