510(k) Report

510(k) · Cleared

Cleared

Portable Oxygen Concentrator, Model RS-00400

K073242510(k) TraditionalCleared Jan 3, 200845-day reviewClass II21 CFR 868.5440

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

Delphi Medical Systems · CAW Generator, Oxygen, Portable

Cleared on Jan 3, 2008 as substantially equivalent to K020324 (Airsep Corp., 2002) after a 45-day review. Its family tree reaches back 1 generation to 2002. 10 later devices descend from it.

Decided
Jan 3, 2008
Review
45 days
Class
Class II
Product code
CAW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K020324 (2002). 10 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2008: 1 descendant cleared2019: 1 descendant cleared2022: 1 descendant cleared2025: 4 descendants cleared2023: 2 descendants clearedK020324 · Lifestyle Oxygen Concentrator · Airsep Corp. · 2002 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants K020324 · Lifestyle Oxygen Concentrator · Airsep Corp. · 2002 · recalled0
  1. Root · 1 generation backK020324 Lifestyle Oxygen ConcentratorAirsep Corp. · 2002 · Recalled
  2. This deviceK073242 Portable Oxygen Concentrator, Model RS-00400Delphi Medical Systems · 2008
  3. Descendant · cites it directly · 8 of its ownK162433 GCE Zen-O Portable Oxygen ConcentratorOxus, Inc. · 2017 · Recalled
  4. Descendant · 2 generations on · 6 of its ownK210371 Portable Oxygen Concentrator, model: P2-E6Qingdao Kingon Medical Science and Technology Co., Ltd. · 2022
  5. Descendant · 3 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
  6. Descendant · 3 generations on · 2 of its ownK223379 Portable Oxygen Concentrator (Model: P2-E7, P2-E)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2023
  7. Descendant · 3 generations on · 1 of its ownK242718 Portable Oxygen Concentrator (P2-TOC)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2025

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2008: 12017: 12019: 12022: 12023: 22025: 4
2008high 4 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 10 · See all
  • K162433GCE Zen-O Portable Oxygen ConcentratorOxus, Inc. · 2017 · cites it directly8descendants
  • K210371Portable Oxygen Concentrator, model: P2-E6Qingdao Kingon Medical Science and Technology Co., Ltd. · 2022 · 2 generations on6descendants
  • K230702Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2023 · 3 generations on3descendants
  • K223379Portable Oxygen Concentrator (Model: P2-E7, P2-E)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2023 · 3 generations on2descendants
  • K242718Portable Oxygen Concentrator (P2-TOC)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2025 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K020324Lifestyle Oxygen ConcentratorAirsep Corp.20023
0 (this device)K073242Portable Oxygen Concentrator, Model RS-00400Delphi Medical Systems2008—
+1K162433GCE Zen-O Portable Oxygen ConcentratorOxus, Inc.20171
+2K210371Portable Oxygen Concentrator, model: P2-E6Qingdao Kingon Medical Science and Technology Co., Ltd.2022—
+3K230702Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)Qingdao Kingon Medical Science and Technology Co., Ltd.2023—
+3K223379Portable Oxygen Concentrator (Model: P2-E7, P2-E)Qingdao Kingon Medical Science and Technology Co., Ltd.2023—
+3K242718Portable Oxygen Concentrator (P2-TOC)Qingdao Kingon Medical Science and Technology Co., Ltd.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201710
201910
202210
202320
202540
FIG. 1 — Lineage of K073242, 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 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 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K020324Lifestyle Oxygen Concentrator
Summary page 1
…21 CFR 868.5440 Predicate Device: Airsep Corporation, LifeStyle Oxygen Concentrator, 510(k) # K020324 Intended Use: The Delphi Portable Oxygen Concentrator is intended to provide supplemental oxygen in a home, institution, or tra…
Airsep Corp.20023

Also cleared against K020324: 4 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K162433GCE Zen-O Portable Oxygen ConcentratorOxus, Inc.20178
K081508HG Oxygen Concentrator, Models HG5-W & HG5-WNShenyang Canta Medical Tech. Co., Ltd.20080

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?

  • Its one ancestor has a recall.
  • Of its descendants, K162433 (Oxus, Inc., 2017) has gone furthest, with 8 descendants of its own.
  • 4 other devices also cite its predicate K020324.

How does its category compare?

All CAW devices

CAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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 Oxygen Concentrator is intended to provide supplemental oxygen in a home, institutional, or travel environment.

Indications for use as stated in the FDA summary.

Also cleared against K020324

4 other devices cite the same predicate.

  • K072688Lifechoice Oxygen Concentrator, Model OXY1000International Biophysics Corp. · 2008
  • K043615Oxytec, Model 900Oxytec Medical Corporation · 2005
  • K033197Inogen Satellite ConserverMedical Electronic Devices, Inc. · 2004
  • K032818Inogen One Oxygen ConcentratorInogen, Inc. · 20041 recall

More from Delphi Medical Systems

2 FDA decisions under this applicant name. See the company

  • K093332Delphi Infusion Pump/ Delphi Administration Set Model IV-01000/ Model IV-02XXXX (Where X IS Any Number…Delphi Medical Systems · 2009

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/K073242 · printed Nov 5, 2026

Cite this page

510(k) Report. “K073242: Portable Oxygen Concentrator, Model RS-00400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073242

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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