510(k) Report

510(k) · Cleared

Recalled · 2007

Mobile Oxygen Storage Tank (Most)

K040738510(k) TraditionalCleared Apr 30, 200439-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

Pacific Consolidated Industries Llp · CAW Generator, Oxygen, Portable

Cleared on Apr 30, 2004 as substantially equivalent to K020330 (Pacific Consolidated Industries Llp, 2002) and 1 other predicate after a 39-day review. Its family tree reaches back 5 generations to 1994. 2 later devices descend from it. It has been recalled once.

Decided
Apr 30, 2004
Review
39 days
Class
Class II
Product code
CAW
Recalls
1
Predicates
2

Its longest line of descent runs back 5 generations to K933081 (1994). 10 ancestors in all, the oldest K904087 (1990). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors1997: 2 other ancestors1990: 1 other ancestor2007: 1 descendant cleared2011: 1 descendant clearedK933081 · Oxlife Oxygen Concentrator · Oxlife, Inc. · 1994K955549 · Oxlife Oxygen Concentrators · Oxlife, Inc. · 1996×3: 3 generations cleared close together, K011844 (2001), K014078 (2002), K020330 (2002) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor4 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K020330 · Deployable Oxygen Concentration System (Docs) · Pacific Consolidated Industries Llp · 2002K014078 · ON Site Gas Systems Portable Oxygen Generator System · On Site Gas Systems, Inc. · 2002K011844 · Merits Health Products Oxygen Concentrators · Merits Health Products., Inc. · 2001K955549 · 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 backK011844 Merits Health Products Oxygen ConcentratorsMerits Health Products., Inc. · 2001
  4. 2 generations backK014078 ON Site Gas Systems Portable Oxygen Generator SystemOn Site Gas Systems, Inc. · 2002
  5. 1 generation backK020330 Deployable Oxygen Concentration System (Docs)Pacific Consolidated Industries Llp · 2002
  6. This deviceK040738 Mobile Oxygen Storage Tank (Most)Pacific Consolidated Industries Llp · 2004
  7. Descendant · cites it directly · 1 of its ownK061414 Expeditionary Delployable Oxygen Concentration System (Edocs)…Pacific Consolidated Industries, LLC · 2007 · Recalled
  8. Descendant · 2 generations on · 0 of its ownK100957 Deployable Oxygen Concentration System (Docs), Model 66, Deployable…Pacific Consolidated Industries, LLC · 2011

Most influential descendants

Showing 2 of 2 · See all
  • K061414Expeditionary Delployable Oxygen Concentration System (Edocs), Models 120B and 30;Mobile…Pacific Consolidated Industries, LLC · 2007 · cites it directly1descendant
  • K100957Deployable Oxygen Concentration System (Docs), Model 66, Deployable Oxygen CeoncentrationPacific Consolidated Industries, LLC · 2011 · 2 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—
−3K011844Merits Health Products Oxygen ConcentratorsMerits Health Products., Inc.2001—
−2K014078ON Site Gas Systems Portable Oxygen Generator SystemOn Site Gas Systems, Inc.2002—
−1K020330Deployable Oxygen Concentration System (Docs)Pacific Consolidated Industries Llp2002—
0 (this device)K040738Mobile Oxygen Storage Tank (Most)Pacific Consolidated Industries Llp2004—
+1K061414Expeditionary Delployable Oxygen Concentration System (Edocs), Models 120B and…Pacific Consolidated Industries, LLC20071
+2K100957Deployable Oxygen Concentration System (Docs), Model 66, Deployable Oxygen…Pacific Consolidated Industries, LLC2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199720
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201110
FIG. 1 — Lineage of K040738, 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
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What was it cleared against? (2)

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
*K020330Deployable Oxygen Concentration System (Docs)
Summary page 2
…k (MOST) Predicate Legally Marketed Device Equivalence Substantial equivalence is claimed to the following legally marketed predicate devices: K020330 - Deployable Oxygen Concentration System (DOCS) K003939 - Venture IOH 200 Home Fill II Complete Home Oxygen System by…
Pacific Consolidated Industries Llp2002—
*K003939Venture Home Fill II, Model Ioh 200
Summary page 2
…quivalence Substantial equivalence is claimed to the following legally marketed predicate devices: K020330 - Deployable Oxygen Concentration System (DOCS) K003939 - Venture IOH 200 Home Fill II Complete Home Oxygen System by Invacare Corporation Both the DOCS and the Home Fill device…
Invacare Corp.20011

Also cleared against K020330: 4 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061414Expeditionary Delployable Oxygen Concentration System (Edocs), Models 120B and 30;Mobile…Pacific Consolidated Industries, LLC20071

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 8, 2007Not classifiedZ-2201-2008Vendor change controlThe recall was initiated after the firm received two customer complaints of ruptured bourdon tubes that had resulted in bellowed out face gauges. With one unit the operator was able to shut off the oxygen flow, however one rupture…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
  • 1 of the 10 ancestors has a recall of any class.
  • Of its descendants, K061414 (Pacific Consolidated Industries, LLC, 2007) has gone furthest, with 1 descendant of its own.
  • 4 other devices also cite its predicate K020330.

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 Mobile Oxygen Storage Tank (MOST) is intended to provide 93% oxygen at 50 psig nominal pressure for supplemental oxygen use only. The MOST is intended to be filled from the Expeditionary Deployable Oxygen Concentration System (E-DOCS) only. The MOST is intended for military use only.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K040738: Mobile Oxygen Storage Tank (Most).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040738

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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