510(k) Report

510(k) · Cleared

Cleared

Deployable Oxygen Generation System-Smaill (DOGS-S)

K150930510(k) TraditionalCleared Dec 18, 2015256-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

Airsep Corporation · CAW Generator, Oxygen, Portable

Cleared on Dec 18, 2015 as substantially equivalent to K083163 (Sequal Technologies, Inc., 2009) after a 256-day review. Its family tree reaches back 5 generations to 1994. 6 later devices descend from it.

Decided
Dec 18, 2015
Review
256 days
Class
Class II
Product code
CAW
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K933081 (1994). 7 ancestors in all, the oldest K852650 (1985). 6 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1985: 1 other ancestor2018: 1 descendant cleared2023: 1 descendant cleared2025: 3 descendants cleared2024: 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 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor4 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants K083163 · 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 · 5 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
  2. 4 generations backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
  3. 3 generations backK963042 Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 1996
  4. 2 generations backK013931 Omni Oxygen System, Model 1000Sequal Technologies, Inc. · 2002 · Recalled
  5. 1 generation backK083163 Omni 2 Oxygen SystemSequal Technologies, Inc. · 2009 · Recalled
  6. This deviceK150930 Deployable Oxygen Generation System-Smaill (DOGS-S)Airsep Corporation · 2015
  7. Descendant · cites it directly · 3 of its ownK222920 Oxygen concentratorZhengzhou Olive Electronic Technology Co., Ltd. · 2023
  8. Descendant · 2 generations on · 2 of its ownK240840 Oxygen Concentrator (ZY-10AB/115)Foshan Care Medical Technology Co., Ltd. · 2024
  9. Descendant · 3 generations on · 0 of its ownK251534 Oxygen Concentrator (J10A)Foshan Kycare Medical Equipment Co., Ltd. · 2025
  10. Descendant · cites it directly · 0 of its ownK251764 Oxygen Concentrator-P2-O5EQingdao Kingon Medical Science and Technology Co., Ltd. · 2025
  11. Descendant · 3 generations on · 0 of its ownK251607 Oxygen Concentrator (J5A)Foshan Kycare Medical Equipment Co., Ltd. · 2025

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2018: 12023: 12024: 12025: 3
2018high 3 (2025) · low 0 (2019)2026

Most influential descendants

Showing 5 of 6 · See all
  • K222920Oxygen concentratorZhengzhou Olive Electronic Technology Co., Ltd. · 2023 · cites it directly3descendants
  • K240840Oxygen Concentrator (ZY-10AB/115)Foshan Care Medical Technology Co., Ltd. · 2024 · 2 generations on2descendants
  • K251534Oxygen Concentrator (J10A)Foshan Kycare Medical Equipment Co., Ltd. · 2025 · 3 generations on0descendants
  • K251764Oxygen Concentrator-P2-O5EQingdao Kingon Medical Science and Technology Co., Ltd. · 2025 · cites it directly0descendants
  • K251607Oxygen Concentrator (J5A)Foshan Kycare Medical Equipment Co., Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K933081Oxlife Oxygen ConcentratorOxlife, Inc.1994—
−4K955549Oxlife Oxygen ConcentratorsOxlife, Inc.1996—
−3K963042Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L.1996—
−2K013931Omni Oxygen System, Model 1000Sequal Technologies, Inc.20021
−1K083163Omni 2 Oxygen SystemSequal Technologies, Inc.20091
0 (this device)K150930Deployable Oxygen Generation System-Smaill (DOGS-S)Airsep Corporation2015—
+1K222920Oxygen concentratorZhengzhou Olive Electronic Technology Co., Ltd.2023—
+2K240840Oxygen Concentrator (ZY-10AB/115)Foshan Care Medical Technology Co., Ltd.2024—
+3K251534Oxygen Concentrator (J10A)Foshan Kycare Medical Equipment Co., Ltd.2025—
+1K251764Oxygen Concentrator-P2-O5EQingdao Kingon Medical Science and Technology Co., Ltd.2025—
+3K251607Oxygen Concentrator (J5A)Foshan Kycare Medical Equipment Co., Ltd.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202310
202410
202530
FIG. 1 — Lineage of K150930, 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? (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
*K083163Omni 2 Oxygen System
Summary page 4
…atory Therapy Devices Predicate Devices: OMNI 2 (SAROS) from SeQual Technologies / A Chart Industries Company Product Code: CAW 510(k) number: K083163 Airsep Corporation 260 Creekside Drive, Buffalo, NY 14228. Phone 716 691 0202 fax 716 691 1255…
Sequal Technologies, Inc.20091

Also cleared against K083163: 2 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K222920Oxygen concentratorZhengzhou Olive Electronic Technology Co., Ltd.20233
K251764Oxygen Concentrator-P2-O5EQingdao Kingon Medical Science and Technology Co., Ltd.20250
K172234Oxygen ConcentratorSysmed (China) Co., Ltd.20180

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 21 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • Of its descendants, K222920 (Zhengzhou Olive Electronic Technology Co., Ltd., 2023) has gone furthest, with 3 descendants of its own.
  • 2 other devices also cite its predicate K083163.

How does its category compare?

All CAW devices

CAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Deployable Oxygen Generator System – Small (DOGS-S) is intended for the administration of supplemental oxygen.

This device is not intended for life support nor does it provide any patient monitoring capabilities. The system will be operated by trained personnel.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K150930: Deployable Oxygen Generation System-Smaill (DOGS-S).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150930

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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