510(k) Report

510(k) · Cleared

Recalled · Class I · 2022

Liberator/Stroller II System

K800742510(k) TraditionalCleared May 23, 198050-day reviewClass II21 CFR 868.5655Recalls 4 (4 Class I)

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

Cryogenic Assoc. · BYJ Unit, Liquid-Oxygen, Portable

Cleared on May 23, 1980 after a 50-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 9 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it. It has been recalled 4 times, including 4 Class I recalls.

Decided
May 23, 1980
Review
50 days
Class
Class II
Product code
BYJ
Recalls
4 (4 Class I)
Predicates
0

8 later devices descend from it, 1 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2001: 1 descendant cleared2007: 2 descendants cleared2005: 1 descendant cleared2008: 1 descendant cleared2009: 1 descendant cleared2020: 1 descendant cleared2022: 1 descendant cleared19801990200020102020
  1. This deviceK800742 Liberator/Stroller II SystemCryogenic Assoc. · 1980
  2. Descendant · cites it directly · 7 of its ownK013251 Spirit 300Caire, Inc. · 2001
  3. Descendant · 2 generations on · 3 of its ownK072011 Copd Liquid Oxygen Portable, Model 300PCopd Partners, Inc. · 2007
  4. Descendant · 3 generations on · 2 of its ownK090421 Model 350G Gas ConserverInspired Technologies, Inc. · 2009
  5. Descendant · 2 generations on · 1 of its ownK050153 Spirit, Model HasCaire, Inc. · 2005 · Recalled
  6. Descendant · 4 generations on · 0 of its ownK221014 Effortless Oxygen Conserver System Models Effortless Pro and…Effortless Oxygen, LLC · 2022

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2001: 12005: 12007: 22008: 12009: 12020: 12022: 1
2001high 2 (2007) · low 0 (2002)2026

Most influential descendants

Showing 5 of 8 · See all
  • K013251Spirit 300Caire, Inc. · 2001 · cites it directly7descendants
  • K072011Copd Liquid Oxygen Portable, Model 300PCopd Partners, Inc. · 2007 · 2 generations on3descendants
  • K090421Model 350G Gas ConserverInspired Technologies, Inc. · 2009 · 3 generations on2descendants
  • K050153Spirit, Model HasCaire, Inc. · 2005 · 2 generations on1descendant
  • K221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLC · 2022 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K800742Liberator/Stroller II SystemCryogenic Assoc.1980—
+1K013251Spirit 300Caire, Inc.2001—
+2K072011Copd Liquid Oxygen Portable, Model 300PCopd Partners, Inc.2007—
+3K090421Model 350G Gas ConserverInspired Technologies, Inc.2009—
+2K050153Spirit, Model HasCaire, Inc.20051
+4K221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLC2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200510
200720
200810
200910
202010
202210
FIG. 1 — Lineage of K800742, 1980–2022Source: 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.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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? (8)

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

NumberDeviceApplicantDecidedDescendants
K013251Spirit 300Caire, Inc.20017

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 10, 2022Class IZ-0339-2023Process controlAn audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
Oct 10, 2022Class IZ-0336-2023Process controlAn audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
Oct 10, 2022Class IZ-0338-2023Process controlAn audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
Oct 10, 2022Class IZ-0337-2023Process controlAn audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K013251 (Caire, Inc., 2001) has gone furthest, with 7 descendants of its own.

How does its category compare?

All BYJ devices

BYJ Unit, Liquid-Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BYJ

1in 2013

2007: 22008: 32010: 12011: 12012: 12013: 1
2007high 3 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BYJ

164in 2008

2008: 164 days median
2007high 164 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BYJ

4in 2022

2007: 12022: 4, 4 Class I
2007high 4 (2022) · low 0 (2008)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · BYJ

1in 2025

2007: 242008: 332009: 122010: 242011: 152012: 112013: 222014: 252015: 342016: 192017: 182018: 212019: 242020: 392021: 72022: 42023: 102024: 102025: 1
2007high 39 (2020) · low 1 (2025)2025

MAUDE reports naming product code BYJ, 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
20072—124
20083164033
20090—012
20101—024
20111—015
20121—011
20131—022
20140—025
20150—034
20160—019
20170—018
20180—021
20190—024
20200—039
20210—07
20220—4 (4)4
20230—010
20240—010
20250—01
20260—0—

More from Cryogenic Assoc.

6 FDA decisions under this applicant name. See the company

  • K883590OxytrolCryogenic Assoc. · 1988
  • K852663Portable Gaseous Oxgyen ContainerCryogenic Assoc. · 1985
  • K841808Stroller SprintCryogenic Assoc. · 1984
  • K822789Roomate IICryogenic Assoc. · 1982
  • K801104Roommate-Oxygen ConcentratorCryogenic Assoc. · 1980

Recent decisions in BYJ

The BYJ category page

  • K130068Dismounted Medical & Supplemental Oxygen System (Dmos)Essex Industries, Inc. D/B/A Essex Cryogenics of M · 2013
  • K113767Mounted Medical Oxygen SystemEssex Industries, Inc. · 2012
  • K103324Precision Liquid Oxygen SystemPrecision Medical, Inc. · 2011
  • K101272Mass Oxygen Distribution System (Mods) Model 10C-0061-3Essex Industries, Inc. · 2010
  • K081779GOLOX-93Respironics, Inc. · 2008

https://510kreport.com/device/K800742 · printed Nov 6, 2026

Cite this page

510(k) Report. “K800742: Liberator/Stroller II System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K800742

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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