510(k) Report

510(k) · Cleared

Cleared

Merits Health Products Oxygen Concentrators

K011844510(k) TraditionalCleared Aug 28, 200177-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

Merits Health Products., Inc. · CAW Generator, Oxygen, Portable

Cleared on Aug 28, 2001 as substantially equivalent to K955549 (Oxlife, Inc., 1996) and 3 other predicates after a 77-day review. Its family tree reaches back 2 generations to 1994. 16 later devices descend from it.

Decided
Aug 28, 2001
Review
77 days
Class
Class II
Product code
CAW
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K933081 (1994). 5 ancestors in all, the oldest K904087 (1990). 16 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 2 other ancestors1990: 1 other ancestor2002: 5 descendants cleared2006: 1 descendant cleared2004: 3 descendants cleared2008: 1 descendant cleared2007: 3 descendants cleared2011: 2 descendants cleared2010: 1 descendant clearedK933081 · Oxlife Oxygen Concentrator · Oxlife, Inc. · 1994K955549 · Oxlife Oxygen Concentrators · Oxlife, Inc. · 19961990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 6 descendants4 generations forward: 1 descendant5 generations forward: 2 descendants K955549 · Oxlife Oxygen Concentrators · Oxlife, Inc. · 1996K933081 · Oxlife Oxygen Concentrator · Oxlife, Inc. · 19940+5
  1. Root · 2 generations backK933081 Oxlife Oxygen ConcentratorOxlife, Inc. · 1994
  2. 1 generation backK955549 Oxlife Oxygen ConcentratorsOxlife, Inc. · 1996
  3. This deviceK011844 Merits Health Products Oxygen ConcentratorsMerits Health Products., Inc. · 2001
  4. Descendant · cites it directly · 13 of its ownK014078 ON Site Gas Systems Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002
  5. Descendant · cites it directly · 6 of its ownK020362 P.O.G.S. 3.3 Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002
  6. Descendant · 2 generations on · 5 of its ownK020330 Deployable Oxygen Concentration System (Docs)Pacific Consolidated Industries Llp · 2002
  7. Descendant · 2 generations on · 4 of its ownK030920 POGS 33On Site Gas Systems, Inc. · 2004
  8. Descendant · 3 generations on · 3 of its ownK041664 Portable Oxygen Generation System: Pogs 33COn Site Gas Systems, Inc. · 2004

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2002: 52004: 32006: 12007: 32008: 12010: 12011: 2
2002high 5 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 16 · See all
  • K014078ON Site Gas Systems Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002 · cites it directly13descendants
  • K020362P.O.G.S. 3.3 Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002 · cites it directly6descendants
  • K020330Deployable Oxygen Concentration System (Docs)Pacific Consolidated Industries Llp · 2002 · 2 generations on5descendants
  • K030920POGS 33On Site Gas Systems, Inc. · 2004 · 2 generations on4descendants
  • K041664Portable Oxygen Generation System: Pogs 33COn Site Gas Systems, Inc. · 2004 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K933081Oxlife Oxygen ConcentratorOxlife, Inc.1994—
−1K955549Oxlife Oxygen ConcentratorsOxlife, Inc.1996—
0 (this device)K011844Merits Health Products Oxygen ConcentratorsMerits Health Products., Inc.2001—
+1K014078ON Site Gas Systems Portable Oxygen Generator SystemOn Site Gas Systems, Inc.2002—
+1K020362P.O.G.S. 3.3 Portable Oxygen Generator SystemOn Site Gas Systems, Inc.2002—
+2K020330Deployable Oxygen Concentration System (Docs)Pacific Consolidated Industries Llp2002—
+2K030920POGS 33On Site Gas Systems, Inc.2004—
+3K041664Portable Oxygen Generation System: Pogs 33COn Site Gas Systems, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199720

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200250
200430
200610
200730
200810
201010
201120
FIG. 1 — Lineage of K011844, 1994–2011Source: 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? (4)

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
*K955549Oxlife Oxygen Concentrators
Summary page 1
…Oxygen Generator 9.5 Comparison to Currently Marketed Devices The Merits Health Products Oxygen Concentrators are substantially equivalent to the OxLife Concentrators (K955549 and K971964), AirSep NewLife Oxygen Concentrators (Last Submission - K960309) and Invacare Oxygen Concentrators (K904087). 9.6…
Oxlife, Inc.1996—
*K971964Oxlife Excell Oxygen Concentrators
Summary page 1
…ator 9.5 Comparison to Currently Marketed Devices The Merits Health Products Oxygen Concentrators are substantially equivalent to the OxLife Concentrators (K955549 and K971964), AirSep NewLife Oxygen Concentrators (Last Submission - K960309) and Invacare Oxygen Concentrators (K904087). 9.6 Device Descr…
Oxlife, Inc.1997—
*K960309Airsep Newlife Dual Six Oxygen Concentrator (Modification)
Summary page 1
…alth Products Oxygen Concentrators are substantially equivalent to the OxLife Concentrators (K955549 and K971964), AirSep NewLife Oxygen Concentrators (Last Submission - K960309) and Invacare Oxygen Concentrators (K904087). 9.6 Device Description The Merits Health Products Oxygen Concentrators are presc…
Airsep Corp.1997—
*K904087Mobilaire Iii and V Model Irc 301 and 501 Oxy. Con
Summary page 1
…ntially equivalent to the OxLife Concentrators (K955549 and K971964), AirSep NewLife Oxygen Concentrators (Last Submission - K960309) and Invacare Oxygen Concentrators (K904087). 9.6 Device Description The Merits Health Products Oxygen Concentrators are prescription devices designed to provide an inexpe…
Invacare Corp.1990—

Also cleared against K955549: 3 other devices →

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K014078ON Site Gas Systems Portable Oxygen Generator SystemOn Site Gas Systems, Inc.200213
K020362P.O.G.S. 3.3 Portable Oxygen Generator SystemOn Site Gas Systems, Inc.20026
K053229Merits Health Products Oxygen ConcentratorsMerits Health Products Co., Ltd.20060
K014301Modification to Merits Health Products Oxygen ConcentratorsMerits Health Products Co., Ltd.20020

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 7 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K014078 (On Site Gas Systems, Inc., 2002) has gone furthest, with 13 descendants of its own.
  • 3 other devices also cite its predicate K955549.

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 Oxygen Concentrator is indicated for the delivery of supplemental oxygen in the home or medical institutions. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K955549

3 other devices cite the same predicate.

  • K020362P.O.G.S. 3.3 Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002
  • K014078ON Site Gas Systems Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002
  • K963042Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 1996

More from Merits Health Products., Inc.

12 FDA decisions under this applicant name. See the company

  • K012802MP3CF Electric WheelchairMerits Health Products., Inc. · 20011 recall
  • K011513MP3U, Power WheelchairMerits Health Products., Inc. · 20011 recall
  • K011751Travel Ease Electric Scooter, Model Pioneer 3Merits Health Products., Inc. · 20011 recall
  • K011753Travel Ease Electric Scooter, Model Pioneer 4Merits Health Products., Inc. · 20011 recall
  • K011687MP-3C Power Base Chair, Model MP3CMerits Health Products., Inc. · 20011 recall

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/K011844 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011844: Merits Health Products Oxygen Concentrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011844

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026