510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Lifestyle Oxygen Concentrator

K020324510(k) TraditionalCleared Mar 13, 200241-day reviewClass II21 CFR 868.5440Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Airsep Corp. · CAW Generator, Oxygen, Portable

Cleared on Mar 13, 2002 after a 41-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 27 later devices descend from it. It has been recalled 3 times.

Decided
Mar 13, 2002
Review
41 days
Class
Class II
Product code
CAW
Recalls
3
Predicates
0

27 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2004: 2 descendants cleared2008: 3 descendants cleared2023: 3 descendants cleared2012: 1 descendant cleared2007: 1 descendant cleared2014: 2 descendants cleared2011: 3 descendants cleared2017: 1 descendant cleared2016: 1 descendant cleared2020: 1 descendant cleared2019: 2 descendants cleared2022: 1 descendant cleared2025: 4 descendants cleared200020052010201520202025
  1. This deviceK020324 Lifestyle Oxygen ConcentratorAirsep Corp. · 2002
  2. Descendant · cites it directly · 10 of its ownK073242 Portable Oxygen Concentrator, Model RS-00400Delphi Medical Systems · 2008
  3. Descendant · 2 generations on · 8 of its ownK162433 GCE Zen-O Portable Oxygen ConcentratorOxus, Inc. · 2017 · Recalled
  4. Descendant · cites it directly · 8 of its ownK032818 Inogen One Oxygen ConcentratorInogen, Inc. · 2004 · Recalled
  5. Descendant · 3 generations on · 6 of its ownK210371 Portable Oxygen Concentrator, model: P2-E6Qingdao Kingon Medical Science and Technology Co., Ltd. · 2022
  6. Descendant · 4 generations on · 3 of its ownK230702 Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2023

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2004: 22005: 22007: 12008: 32011: 32012: 12014: 22016: 12017: 12019: 22020: 12022: 12023: 32025: 4
2004high 4 (2025) · low 0 (2006)2026

Most influential descendants

Showing 5 of 27 · See all
  • K073242Portable Oxygen Concentrator, Model RS-00400Delphi Medical Systems · 2008 · cites it directly10descendants
  • K162433GCE Zen-O Portable Oxygen ConcentratorOxus, Inc. · 2017 · 2 generations on8descendants
  • K032818Inogen One Oxygen ConcentratorInogen, Inc. · 2004 · cites it directly8descendants
  • K210371Portable Oxygen Concentrator, model: P2-E6Qingdao Kingon Medical Science and Technology Co., Ltd. · 2022 · 3 generations on6descendants
  • K230702Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2023 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K020324Lifestyle Oxygen ConcentratorAirsep Corp.2002—
+1K073242Portable Oxygen Concentrator, Model RS-00400Delphi Medical Systems2008—
+2K162433GCE Zen-O Portable Oxygen ConcentratorOxus, Inc.20171
+1K032818Inogen One Oxygen ConcentratorInogen, Inc.20041
+3K210371Portable Oxygen Concentrator, model: P2-E6Qingdao Kingon Medical Science and Technology Co., Ltd.2022—
+4K230702Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)Qingdao Kingon Medical Science and Technology Co., Ltd.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200520
200710
200830
201130
201210
201420
201610
201710
201920
202010
202210
202330
202540
FIG. 1 — Lineage of K020324, 2002–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 CAW? 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 CAW device

  1. #1 K230052 Inogen Rove 6score 29.9 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (27)

See all 27

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K073242Portable Oxygen Concentrator, Model RS-00400Delphi Medical Systems200810
K032818Inogen One Oxygen ConcentratorInogen, Inc.20048
K043615Oxytec, Model 900Oxytec Medical Corporation20053
K072688Lifechoice Oxygen Concentrator, Model OXY1000International Biophysics Corp.20082
K033197Inogen Satellite ConserverMedical Electronic Devices, Inc.20041

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 4, 2024Class IIZ-0479-2025Nonconforming Material/ComponentPotential failure of affected units to recharge the battery of the oxygen concentrators.
Oct 4, 2024Class IIZ-0478-2025Nonconforming Material/ComponentPotential failure of affected units to recharge the battery of the oxygen concentrators.
Jan 14, 2013Class IIZ-0768-2013Nonconforming Material/ComponentDue to past battery inventory storage conditions and deficiencies in the maintenance procedure, it was possible that some batteries were over-discharged to point of damaging the cells.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K073242 (Delphi Medical Systems, 2008) has gone furthest, with 10 descendants of its own.

How does its category compare?

All CAW devices

CAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAW

12in 2025

2007: 62008: 112009: 82010: 52011: 62012: 52013: 22014: 62015: 12016: 12017: 12018: 32019: 22020: 52021: 22022: 42023: 82024: 22025: 122026 (partial year): 6
2007high 12 (2025) · low 1 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAW

178in 2025

2007: 143 days median2008: 90 days median2009: 193 days median2010: 133 days median2011: 174 days median2012: 148 days median2014: 277 days median2018: 203 days median2020: 224 days median2022: 458 days median2023: 261 days median2025: 178 days median2026 (partial year): 260 days median
2007high 458 (2022) · low 90 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CAW

1in 2025

2007: 12008: 32009: 22011: 12013: 22014: 22016: 12017: 12019: 22020: 12022: 22024: 5, 1 Class I2025: 1
2007high 5 (2024) · low 0 (2010)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · CAW

611in 2025

2007: 232008: 252009: 432010: 482011: 1672012: 3952013: 2,3092014: 24,5382015: 18,9732016: 3,1672017: 1072018: 1162019: 1202020: 1252021: 1942022: 3052023: 3572024: 4502025: 611
2007high 24,538 (2014) · low 23 (2007)2025

MAUDE reports naming product code CAW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20076143123
20081190325
20098193243
20105133048
201161741167
201251480395
20132—22,309
20146277224,538
20151—018,973
20161—13,167
20171—1107
201832030116
20192—2120
202052241125
20212—0194
202244582305
202382610357
20242—5 (1)450
2025121781611
202662600—

What is it indicated for?

The portable AirSep LifeStyle Oxygen Concentrator is intended to provide supplemental, high-purity oxygen in a home, institutional, or travel environment.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Airsep Corp.

18 FDA decisions under this applicant name. See the company

  • K101154Centrox, Reliant, Ultrox, as-D+, as-E, as-G, as-J, as-K and as-LAirsep Corp. · 2011
  • K080348Oxiscan II Data Management SystemAirsep Corp. · 2008
  • K012037Healthlife Oxygen Concentrator Model AS009Airsep Corp. · 2002
  • K000963DA Vinchi Eeg and Emg/EP SystemsAirsep Corp. · 2000
  • K001579Impulse SelectAirsep Corp. · 2000

Recent decisions in CAW

The CAW category page

  • K254289Portable Oxygen Concentrator (OX-1A-E, OX-1B)Oxytek Medical Technology Co., Ltd. · 2026
  • K260171Portable Oxygen Concentrator (PO1 5B, PO1 6B)BMC Medical Co., Ltd. · 2026
  • K252399Portable Oxygen ConcentratorHonsun (Nantong) Co., Ltd. · 2026
  • K252965Oxygen Concentrator (OX-5A, OX-5C)Oxytek Medical Technology Co., Ltd. · 2026
  • K252407OxyGo Portable Oxygen Concentrator (1400-7000)Mv Life, LLC · 2026

https://510kreport.com/device/K020324 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020324: Lifestyle Oxygen Concentrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020324

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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