510(k) Report

510(k) · Cleared

Cleared

Portable Oxygen Concentrator (P2-TOC)

K242718510(k) TraditionalCleared Feb 28, 2025171-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

Qingdao Kingon Medical Science and Technology Co., Ltd. · CAW Generator, Oxygen, Portable

Cleared on Feb 28, 2025 as substantially equivalent to K230702 (Qingdao Kingon Medical Science and Technology Co., Ltd., 2023) and 5 other predicates after a 171-day review. Its family tree reaches back 6 generations to 1994. 1 later device descends from it.

Decided
Feb 28, 2025
Review
171 days
Class
Class II
Product code
CAW
Recalls
None
Predicates
6

Its longest line of descent runs back 6 generations to K933081 (1994). 16 ancestors in all, the oldest K852650 (1985). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2023: 2 other ancestors2022: 1 other ancestor2020: 1 other ancestor2017: 1 other ancestor2011: 1 other ancestor2001: 1 other ancestor2008: 1 other ancestor1985: 1 other ancestor2002: 1 other ancestor2025: 1 descendant clearedK933081 · Oxlife Oxygen Concentrator · Oxlife, Inc. · 1994K955549 · Oxlife Oxygen Concentrators · Oxlife, Inc. · 1996K963042 · Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853 · Sim Italia S.R.L. · 1996K013931 · Omni Oxygen System, Model 1000 · Sequal Technologies, Inc. · 2002 · recalledK083163 · Omni 2 Oxygen System · Sequal Technologies, Inc. · 2009 · recalledK120785 · Omni 3 Oxygen System · Caire, Inc. · 20121990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors3 generations back: 2 other ancestors4 generations back: 1 other ancestor 1 generation forward: 1 descendant K120785 · Omni 3 Oxygen System · Caire, Inc. · 2012K083163 · Omni 2 Oxygen System · Sequal Technologies, Inc. · 2009 · recalledK013931 · Omni Oxygen System, Model 1000 · Sequal Technologies, Inc. · 2002 · recalledK963042 · Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853 · Sim Italia S.R.L. · 1996K955549 · Oxlife Oxygen Concentrators · Oxlife, Inc. · 1996K933081 · Oxlife Oxygen Concentrator · Oxlife, Inc. · 1994−50
  1. Root · 6 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
  2. 5 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
  3. 4 generations backK963042 Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 1996
  4. 3 generations backK013931 Omni Oxygen System, Model 1000Sequal Technologies, Inc. · 2002 · Recalled
  5. 2 generations backK083163 Omni 2 Oxygen SystemSequal Technologies, Inc. · 2009 · Recalled
  6. 1 generation backK120785 Omni 3 Oxygen SystemCaire, Inc. · 2012
  7. This deviceK242718 Portable Oxygen Concentrator (P2-TOC)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2025
  8. Descendant · cites it directly · 0 of its ownK252268 V series portable oxygen concentrator (V5, V5C, V6, V6C)Shenzhen Harveymed Technology Co., Ltd. · 2025

Most influential descendants

Showing 1 of 1 · See all
  • K252268V series portable oxygen concentrator (V5, V5C, V6, V6C)Shenzhen Harveymed Technology Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K933081Oxlife Oxygen ConcentratorOxlife, Inc.1994—
−5K955549Oxlife Oxygen ConcentratorsOxlife, Inc.1996—
−4K963042Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L.1996—
−3K013931Omni Oxygen System, Model 1000Sequal Technologies, Inc.20021
−2K083163Omni 2 Oxygen SystemSequal Technologies, Inc.20091
−1K120785Omni 3 Oxygen SystemCaire, Inc.2012—
0 (this device)K242718Portable Oxygen Concentrator (P2-TOC)Qingdao Kingon Medical Science and Technology Co., Ltd.2025—
+1K252268V series portable oxygen concentrator (V5, V5C, V6, V6C)Shenzhen Harveymed Technology Co., Ltd.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
200110
200210
200810
201110
201710
202010
202210
202320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K242718, 1994–2025Source: 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? (6)

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
*K230702Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)
Summary page 5
…mation Product name Portable Oxygen Concentrator. Model: 1 P2-S4,P2-S3,P2-K4,P2-K3 510(k) number K230702 2 Product name Portable Oxygen Concentrator. Model: P2-E7,P2-E…
Qingdao Kingon Medical Science and Technology Co., Ltd.2023—
*K223379Portable Oxygen Concentrator (Model: P2-E7, P2-E)
Summary page 6
…ntrator. Model: P2-E7,P2-E 2 / 12 510(k) number K223379 Product name Portable Oxygen Concentrator. Model: P2-E6 3 510(k) number K210371 Pr…
Qingdao Kingon Medical Science and Technology Co., Ltd.2023—
*K210371Portable Oxygen Concentrator, model: P2-E6
Summary page 6
…2 / 12 510(k) number K223379 Product name Portable Oxygen Concentrator. Model: P2-E6 3 510(k) number K210371 Product name Kingon P2 Oxygen Concentrator 4 510(k) number K190304 V. Device descript…
Qingdao Kingon Medical Science and Technology Co., Ltd.2022—
*K190304Kingon P2 Oxygen Concentrator
Summary page 6
…entrator. Model: P2-E6 3 510(k) number K210371 Product name Kingon P2 Oxygen Concentrator 4 510(k) number K190304 V. Device description and Indications for Use Device description: The Portable Oxygen Concentrator P2-TOC is a device that uses…
Qingdao Kingon Medical Science and Technology Co.2020—
*K013931Omni Oxygen System, Model 1000
Summary page 7
…odel 4000 that manufactured by CAIRE was selected for comparison. See the following table for details of comparison: ID Items Predicate Device (K013931) Reference Device (K120785) Device to be submitted for 501K Comparison 1…
Sequal Technologies, Inc.20021
*K120785Omni 3 Oxygen System
Summary page 7
…elected for comparison. See the following table for details of comparison: ID Items Predicate Device (K013931) Reference Device (K120785) Device to be submitted for 501K Comparison 1 Device Name Omni Portable Oxygen…
Caire, Inc.2012—

Also cleared against K230702: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K252268V series portable oxygen concentrator (V5, V5C, V6, V6C)Shenzhen Harveymed Technology Co., Ltd.20250

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?

  • The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
  • 4 of the 16 ancestors have a recall of any class.
  • Of its descendants, K252268 (Shenzhen Harveymed Technology Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K230702.

How does its category compare?

All CAW devices

CAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 P2-TOC is intended to provide supplemental low flow oxygen.

The device is not intended for life support, nor does it provide any patient monitoring capabilities. This device is for adults only.

Indications for use as stated in the FDA summary.

Also cleared against K230702

1 other device cites the same predicate.

  • K242736Portable Oxygen Concentrator (Spirit-3)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2025

More from Qingdao Kingon Medical Science and…

5 FDA decisions under this applicant name. See the company

  • K251764Oxygen Concentrator-P2-O5EQingdao Kingon Medical Science and Technology Co., Ltd. · 2025
  • K230702Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2023
  • K223379Portable Oxygen Concentrator (Model: P2-E7, P2-E)Qingdao Kingon Medical Science and Technology Co., Ltd. · 2023
  • K210371Portable Oxygen Concentrator, model: P2-E6Qingdao Kingon Medical Science and Technology Co., Ltd. · 2022

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/K242718 · printed Nov 6, 2026

Cite this page

510(k) Report. “K242718: Portable Oxygen Concentrator (P2-TOC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242718

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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