510(k) Report

510(k) · Cleared

Recalled · 2011

Venture Home Fill II, Model Ioh 200

K003939510(k) TraditionalCleared Mar 21, 200190-day reviewClass II21 CFR 868.5440Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Invacare Corp. · CAW Generator, Oxygen, Portable

Cleared on Mar 21, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it. It has been recalled once.

Decided
Mar 21, 2001
Review
90 days
Class
Class II
Product code
CAW
Recalls
1
Predicates
0

11 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2009: 1 descendant cleared2005: 1 descendant cleared2002: 2 descendants cleared2014: 1 descendant cleared2008: 1 descendant cleared2007: 2 descendants cleared2011: 1 descendant cleared2010: 1 descendant cleared200020052010201520202025
  1. This deviceK003939 Venture Home Fill II, Model Ioh 200Invacare Corp. · 2001
  2. Descendant · cites it directly · 5 of its ownK020330 Deployable Oxygen Concentration System (Docs)Pacific Consolidated Industries Llp · 2002
  3. Descendant · cites it directly · 2 of its ownK040738 Mobile Oxygen Storage Tank (Most)Pacific Consolidated Industries Llp · 2004 · Recalled
  4. Descendant · cites it directly · 1 of its ownK091191 Gas TransfillRespironics Inc., Sleep & Home Respiratory Group · 2009
  5. Descendant · 2 generations on · 1 of its ownK061414 Expeditionary Delployable Oxygen Concentration System (Edocs)…Pacific Consolidated Industries, LLC · 2007 · Recalled
  6. Descendant · cites it directly · 1 of its ownK050430 Merits Health Products Oxygen ConcentratorMerits Health Products Co., Ltd. · 2005

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2002: 22004: 12005: 12007: 22008: 12009: 12010: 12011: 12014: 1
2002high 2 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 11 · See all
  • K020330Deployable Oxygen Concentration System (Docs)Pacific Consolidated Industries Llp · 2002 · cites it directly5descendants
  • K040738Mobile Oxygen Storage Tank (Most)Pacific Consolidated Industries Llp · 2004 · cites it directly2descendants
  • K091191Gas TransfillRespironics Inc., Sleep & Home Respiratory Group · 2009 · cites it directly1descendant
  • K061414Expeditionary Delployable Oxygen Concentration System (Edocs), Models 120B and 30;Mobile…Pacific Consolidated Industries, LLC · 2007 · 2 generations on1descendant
  • K050430Merits Health Products Oxygen ConcentratorMerits Health Products Co., Ltd. · 2005 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003939Venture Home Fill II, Model Ioh 200Invacare Corp.2001—
+1K020330Deployable Oxygen Concentration System (Docs)Pacific Consolidated Industries Llp2002—
+1K040738Mobile Oxygen Storage Tank (Most)Pacific Consolidated Industries Llp20041
+1K091191Gas TransfillRespironics Inc., Sleep & Home Respiratory Group2009—
+2K061414Expeditionary Delployable Oxygen Concentration System (Edocs), Models 120B and…Pacific Consolidated Industries, LLC20071
+1K050430Merits Health Products Oxygen ConcentratorMerits Health Products Co., Ltd.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200410
200510
200720
200810
200910
201010
201110
201410
FIG. 1 — Lineage of K003939, 2001–2014Source: 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), 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K020330Deployable Oxygen Concentration System (Docs)Pacific Consolidated Industries Llp20025
K040738Mobile Oxygen Storage Tank (Most)Pacific Consolidated Industries Llp20042
K091191Gas TransfillRespironics Inc., Sleep & Home Respiratory Group20091
K050430Merits Health Products Oxygen ConcentratorMerits Health Products Co., Ltd.20051
K141967Purefill Oxygen CompressorInovo, Inc.20140
K021685Venture Homefill II with Oxygen ConserverInvacare Corp.20020

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 11, 2011Not classifiedZ-1423-2011OtherInvacare Corporation decided to recall the products because risk analysis reveals that inadequate clearance between a motor ground clip and the motor windings may result in an increased risk for shock to service personnel. It also may…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K020330 (Pacific Consolidated Industries Llp, 2002) has gone furthest, with 5 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—

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111 FDA decisions under this applicant name. See the company

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https://510kreport.com/device/K003939 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003939: Venture Home Fill II, Model Ioh 200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003939

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026