510(k) Report

510(k) · Cleared

Cleared

L4 Oxygen Concentrator

K061261510(k) SpecialCleared Jun 28, 200654-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

Respironics, Inc. · CAW Generator, Oxygen, Portable

Cleared on Jun 28, 2006 as substantially equivalent to K972614 (Healthdyne Technologies, Inc., 1998) after a 54-day review. Its family tree reaches back 1 generation to 1998. 6 later devices descend from it.

Decided
Jun 28, 2006
Review
54 days
Class
Class II
Product code
CAW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K972614 (1998). 6 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2008: 2 descendants cleared2014: 2 descendants cleared2023: 1 descendant cleared2013: 1 descendant clearedK972614 · Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator W/Opi Model 605 · Healthdyne Technologies, Inc. · 19981995200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 1 descendant K972614 · Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator W/Opi Model 605 · Healthdyne Technologies, Inc. · 19980
  1. Root · 1 generation backK972614 Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator…Healthdyne Technologies, Inc. · 1998
  2. This deviceK061261 L4 Oxygen ConcentratorRespironics, Inc. · 2006
  3. Descendant · cites it directly · 1 of its ownK082566 Mark 5 Nuvo Lite Ocsi and STDNidek Medical Products, Inc. · 2008
  4. Descendant · cites it directly · 0 of its ownK213825 Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5AJiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2023
  5. Descendant · cites it directly · 0 of its ownK132489 Inogen at Home Oxygen Concentrator (Aka Inogen at Home)Inogen, Inc. · 2014
  6. Descendant · cites it directly · 0 of its ownK132205 Actovox DUO2 Oxygen Concentrator SystemInova Labs, Inc. · 2014
  7. Descendant · 2 generations on · 0 of its ownK123738 Mark 5 Nuvo Lite Ocsi, Mark 5 Nuvo Lite STDNidek Medical Products, Inc. · 2013

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2008: 22013: 12014: 22023: 1
2008high 2 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 6 · See all
  • K082566Mark 5 Nuvo Lite Ocsi and STDNidek Medical Products, Inc. · 2008 · cites it directly1descendant
  • K213825Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5AJiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2023 · cites it directly0descendants
  • K132489Inogen at Home Oxygen Concentrator (Aka Inogen at Home)Inogen, Inc. · 2014 · cites it directly0descendants
  • K132205Actovox DUO2 Oxygen Concentrator SystemInova Labs, Inc. · 2014 · cites it directly0descendants
  • K123738Mark 5 Nuvo Lite Ocsi, Mark 5 Nuvo Lite STDNidek Medical Products, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K972614Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator W/Opi Model…Healthdyne Technologies, Inc.1998—
0 (this device)K061261L4 Oxygen ConcentratorRespironics, Inc.2006—
+1K082566Mark 5 Nuvo Lite Ocsi and STDNidek Medical Products, Inc.2008—
+1K213825Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5AJiangsu Yuyue Medical Equipment & Supply Co., Ltd.2023—
+1K132489Inogen at Home Oxygen Concentrator (Aka Inogen at Home)Inogen, Inc.2014—
+1K132205Actovox DUO2 Oxygen Concentrator SystemInova Labs, Inc.2014—
+2K123738Mark 5 Nuvo Lite Ocsi, Mark 5 Nuvo Lite STDNidek Medical Products, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
201310
201420
202310
FIG. 1 — Lineage of K061261, 1998–2023Source: 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
*K972614Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator W/Opi Model 605
Summary page 1
…oncentrator Proprietary Name Respironics L4 Oxygen Concentrator Predicate Device(s) Respironics "Twister" Oxygen Concentrator (K97261 4) Reason for submission Modified design. ©2006 Respironics Inc. 5/3/2006…
Healthdyne Technologies, Inc.1998—

Also cleared against K972614: 2 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K082566Mark 5 Nuvo Lite Ocsi and STDNidek Medical Products, Inc.20081
K213825Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5AJiangsu Yuyue Medical Equipment & Supply Co., Ltd.20230
K132489Inogen at Home Oxygen Concentrator (Aka Inogen at Home)Inogen, Inc.20140
K132205Actovox DUO2 Oxygen Concentrator SystemInova Labs, Inc.20140
K072348Precision Oxygen ConcentratorPrecision Medical, Inc.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 no recall.
  • Of its descendants, K082566 (Nidek Medical Products, Inc., 2008) has gone furthest, with 1 descendant of its own.
  • 2 other devices also cite its predicate K972614.

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 L4 Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining

For use in the home or hospital/institutional environment.

Indications for use as stated in the FDA summary.

Also cleared against K972614

2 other devices cite the same predicate.

  • K061426Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47Porous Media Corp. · 2006
  • K043006Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605Respironics, Inc. · 2005

More from Respironics, Inc.

173 FDA decisions under this applicant name. See the company

  • K261262Altis Full Face MaskRespironics, Inc. · 2026
  • K243394AF531 Oro-Nasal SE Face MaskRespironics, Inc. · 2024
  • K231313Therapy Mask 3100 NC/SPRespironics, Inc. · 2023
  • K210844DreamWear Silicone Pillows MaskRespironics, Inc. · 2021
  • K210386Magneto Nasal MaskRespironics, Inc. · 20211 Class I 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/K061261 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061261: L4 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/K061261

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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