510(k) · Cleared
ClearedAirsep Impulse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airsep Corp. · NFB Conserver, Oxygen
Cleared on Oct 10, 1996 after an 86-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Oct 10, 1996
- Review
- 86 days
- Class
- Class II
- Product code
- NFB
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK962766 Airsep ImpulseAirsep Corp. · 1996
- Descendant · cites it directly · 3 of its ownK983459 Pulsed Oxygen Conserving Device, PocdMedical Electronic Devices, Inc. · 1998
- Descendant · 2 generations on · 2 of its ownK023420 Pulsed Oxygen Conserving Device - Every Breath, Pocdeb, ReactebMedical Electronic Devices, Inc. · 2002
- Descendant · 3 generations on · 1 of its ownK033197 Inogen Satellite ConserverMedical Electronic Devices, Inc. · 2004
- Descendant · 4 generations on · 0 of its ownK052563 Inogen Satellite Conserver, Model SC-100Medical Electronic Devices, Inc. · 2005
Most influential descendants
Showing 4 of 4 · See all- K983459Pulsed Oxygen Conserving Device, PocdMedical Electronic Devices, Inc. · 1998 · cites it directly3descendants
- K023420Pulsed Oxygen Conserving Device - Every Breath, Pocdeb, ReactebMedical Electronic Devices, Inc. · 2002 · 2 generations on2descendants
- K033197Inogen Satellite ConserverMedical Electronic Devices, Inc. · 2004 · 3 generations on1descendant
- K052563Inogen Satellite Conserver, Model SC-100Medical Electronic Devices, Inc. · 2005 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962766 | Airsep Impulse | Airsep Corp. | 1996 | — |
| +1 | K983459 | Pulsed Oxygen Conserving Device, Pocd | Medical Electronic Devices, Inc. | 1998 | — |
| +2 | K023420 | Pulsed Oxygen Conserving Device - Every Breath, Pocdeb, Reacteb | Medical Electronic Devices, Inc. | 2002 | — |
| +3 | K033197 | Inogen Satellite Conserver | Medical Electronic Devices, Inc. | 2004 | — |
| +4 | K052563 | Inogen Satellite Conserver, Model SC-100 | Medical Electronic Devices, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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? (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 |
|---|---|---|---|
| * | — | Chad Therapeutics Oxymatic Electronic Oxygen Conserver Model 301 Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983459 | Pulsed Oxygen Conserving Device, Pocd | 1998 | 3 |
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, K983459 (Medical Electronic Devices, Inc., 1998) has gone furthest, with 3 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 AirSep Impulse Oxygen Conserving Device is to be normally used in a home or institutional environment for persons who suffer from various forms of Chronic Obstructive Pulmonary Disease (COPD). It is to be used only when a nasal oxygen cannula is prescribed. The Impulse has been designed to work in conjunction with a portable, regulated flow bottled oxygen source. The unit can be used with any oxygen source capable of delivering gaseous oxygen at 20…
Read the full statement (123 words)
The AirSep Impulse Oxygen Conserving Device is to be normally used in a home or institutional environment for persons who suffer from various forms of Chronic Obstructive Pulmonary Disease (COPD). It is to be used only when a nasal oxygen cannula is prescribed.
The Impulse has been designed to work in conjunction with a portable, regulated flow bottled oxygen source. The unit can be used with any oxygen source capable of delivering gaseous oxygen at 20 to 25 psig. Oxygen is delivered in a precise amount at the optimum point in the breathing cycle through the nasal cannula. This form of delivery maximizes the beneficial effects of supplemental oxygen while eliminating unnecessary waste, thus increasing user mobility and ambulatory duration of the user.
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/K962766 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962766: Airsep Impulse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962766
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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