510(k) Report

510(k) · Cleared

Cleared

Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator W/Opi Model 605

K972614510(k) TraditionalCleared Jan 20, 1998190-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

Healthdyne Technologies, Inc. · CAW Generator, Oxygen, Portable

Cleared on Jan 20, 1998 after a 190-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 12 later devices descend from it.

Decided
Jan 20, 1998
Review
190 days
Class
Class II
Product code
CAW
Recalls
None
Predicates
0

12 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared2005: 1 descendant cleared2010: 2 descendants cleared2008: 2 descendants cleared2014: 3 descendants cleared2023: 1 descendant cleared2013: 1 descendant cleared1995200020052010201520202025
  1. This deviceK972614 Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator…Healthdyne Technologies, Inc. · 1998
  2. Descendant · cites it directly · 6 of its ownK061261 L4 Oxygen ConcentratorRespironics, Inc. · 2006
  3. Descendant · cites it directly · 4 of its ownK043006 Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model…Respironics, Inc. · 2005
  4. Descendant · cites it directly · 2 of its ownK061426 Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25…Porous Media Corp. · 2006
  5. Descendant · 2 generations on · 1 of its ownK091363 Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950…Ag Industries · 2010
  6. Descendant · 2 generations on · 1 of its ownK082566 Mark 5 Nuvo Lite Ocsi and STDNidek Medical Products, Inc. · 2008

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2005: 12006: 22008: 22010: 22013: 12014: 32023: 1
2005high 3 (2014) · low 0 (2007)2026

Most influential descendants

Showing 5 of 12 · See all
  • K061261L4 Oxygen ConcentratorRespironics, Inc. · 2006 · cites it directly6descendants
  • K043006Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605Respironics, Inc. · 2005 · cites it directly4descendants
  • K061426Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47Porous Media Corp. · 2006 · cites it directly2descendants
  • K091363Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205…Ag Industries · 2010 · 2 generations on1descendant
  • K082566Mark 5 Nuvo Lite Ocsi and STDNidek Medical Products, Inc. · 2008 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K972614Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator W/Opi Model…Healthdyne Technologies, Inc.1998—
+1K061261L4 Oxygen ConcentratorRespironics, Inc.2006—
+1K043006Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605Respironics, Inc.2005—
+1K061426Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47Porous Media Corp.2006—
+2K091363Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202…Ag Industries2010—
+2K082566Mark 5 Nuvo Lite Ocsi and STDNidek Medical Products, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200620
200820
201020
201310
201430
202310
FIG. 1 — Lineage of K972614, 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 510(k) statement (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
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K061261L4 Oxygen ConcentratorRespironics, Inc.20066
K043006Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605Respironics, Inc.20054
K061426Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47Porous Media Corp.20062

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?

  • Of its descendants, K061261 (Respironics, Inc., 2006) has gone furthest, with 6 descendants of its own.

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 Twister Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring low flow oxygen therapy. This device is not intended to be life supporting nor life sustaining.

The Twister produces concentrated oxygen from room air for delivery to a patient requiring low flow oxygen therapy. The oxygen from the air is concentrated using a molecular sieve and a pressure swing adsorption process.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Healthdyne Technologies, Inc.

9 FDA decisions under this applicant name. See the company

  • K983572Simon Multichannel Recording System, Model 5500Healthdyne Technologies, Inc. · 1999
  • K974453Nasal Interface Model 7910Healthdyne Technologies, Inc. · 1998
  • K974879Model 7410 VoyagerHealthdyne Technologies, Inc. · 1998
  • K971867Alice 4R SystemHealthdyne Technologies, Inc. · 1997
  • K971545Protege Liquid Oxygen SystemHealthdyne Technologies, Inc. · 1997

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/K972614 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972614: Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator W/Opi Model 605.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972614

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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