510(k) Report

510(k) · Cleared

Cleared

Model 350G Gas Conserver

K090421510(k) TraditionalCleared May 29, 2009100-day reviewClass II21 CFR 868.5905

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

Inspired Technologies, Inc. · NFB Conserver, Oxygen

Cleared on May 29, 2009 as substantially equivalent to K020329 (Sunrise Medical Hhg, Inc., 2002) and 2 other predicates after a 100-day review. Its family tree reaches back 4 generations to 1994. 1 of the 12 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided
May 29, 2009
Review
100 days
Class
Class II
Product code
NFB
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K933930 (1994). 9 ancestors in all, the oldest K800742 (1980). 2 later devices descend from it, 2 citing it directly. 1 of the 12 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2002: 1 other ancestor1996: 1 other ancestor1983: 1 other ancestor1980: 1 other ancestor, 1 with a Class I recall12020: 1 descendant cleared2022: 1 descendant clearedK933930 · Puritan-Bennett Companion 550 Liquid Oxygen Portable Unit · Puritan Bennett Corp. · 1994K993220 · Puritan-Bennett Helios Portable Liquid Oxygen System · Puritan Bennett Corp. · 1999K013251 · Spirit 300 · Caire, Inc. · 2001K072011 · Copd Liquid Oxygen Portable, Model 300P · Copd Partners, Inc. · 200719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor3 generations back: 2 other ancestors, 1 with a Class I recall1 1 generation forward: 2 descendants K072011 · Copd Liquid Oxygen Portable, Model 300P · Copd Partners, Inc. · 2007K013251 · Spirit 300 · Caire, Inc. · 2001K993220 · Puritan-Bennett Helios Portable Liquid Oxygen System · Puritan Bennett Corp. · 1999K933930 · Puritan-Bennett Companion 550 Liquid Oxygen Portable Unit · Puritan Bennett Corp. · 19940
  1. Root · 4 generations backK933930 Puritan-Bennett Companion 550 Liquid Oxygen Portable UnitPuritan Bennett Corp. · 1994
  2. 3 generations backK993220 Puritan-Bennett Helios Portable Liquid Oxygen SystemPuritan Bennett Corp. · 1999
  3. 2 generations backK013251 Spirit 300Caire, Inc. · 2001
  4. 1 generation backK072011 Copd Liquid Oxygen Portable, Model 300PCopd Partners, Inc. · 2007
  5. This deviceK090421 Model 350G Gas ConserverInspired Technologies, Inc. · 2009
  6. Descendant · cites it directly · 0 of its ownK221014 Effortless Oxygen Conserver System Models Effortless Pro and…Effortless Oxygen, LLC · 2022
  7. Descendant · cites it directly · 0 of its ownK200401 ApogeeIncoba Ltd D/B/A Dynaris · 2020

Class I recalls in this family

Most influential descendants

Showing 2 of 2 · See all
  • K221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLC · 2022 · cites it directly0descendants
  • K200401ApogeeIncoba Ltd D/B/A Dynaris · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K933930Puritan-Bennett Companion 550 Liquid Oxygen Portable UnitPuritan Bennett Corp.1994—
−3K993220Puritan-Bennett Helios Portable Liquid Oxygen SystemPuritan Bennett Corp.1999—
−2K013251Spirit 300Caire, Inc.2001—
−1K072011Copd Liquid Oxygen Portable, Model 300PCopd Partners, Inc.2007—
0 (this device)K090421Model 350G Gas ConserverInspired Technologies, Inc.2009—
+1K221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLC2022—
+1K200401ApogeeIncoba Ltd D/B/A Dynaris2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198011
198310
199610
200210
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202210
FIG. 1 — Lineage of K090421, 1994–2022Source: 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), 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.

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.

Top candidate predicates for a new NFB device

  1. #1 K250322 Respond OC Conserving Regulator (130-0800)score 10.6 · 4 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? (3)

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
*K020329Devilbiss PD1000
Summary page 1
…ssification Name: Noncontinuous ventilator (IPPB) NFB - 868.5905 Predicate Devices: Sunrise PD 1000 - K020329 Inspired Technologies VIAspire Model 300P LOX portable -…
Sunrise Medical Hhg, Inc.20022
*K072011Copd Liquid Oxygen Portable, Model 300P
Summary page 1
…Sunrise PD 1000 - K020329 Inspired Technologies VIAspire Model 300P LOX portable - K072011 Essex - Hi Pressure OCD - K024023 Device Description: The Inspired Technologies Model 350G Gas…
Copd Partners, Inc.2007—
*K024023Essex High Pressure (HP) Ocd and Essex Escort Pneumatic Conserver
Summary page 1
…Inspired Technologies VIAspire Model 300P LOX portable - K072011 Essex - Hi Pressure OCD - K024023 Device Description: The Inspired Technologies Model 350G Gas Conserver is designed to extend the use time of oxygen cylinders. I…
Essex Medical Systems Plus2003—

Also cleared against K020329: 2 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLC20220
K200401ApogeeIncoba Ltd D/B/A Dynaris20200

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

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K800742Liberator/Stroller II SystemCryogenic Assoc. · 1980 · 3 generations back · ◆ in the 1980 ancestors bar of FIG. 14 Class I recalls

What does this lineage say?

  • The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
  • 2 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K221014 (Effortless Oxygen, LLC, 2022) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K020329.

How does its category compare?

All NFB devices

NFB Conserver, Oxygen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · NFB

1in 2025

2007: 12009: 12010: 12011: 12013: 12016: 12020: 12022: 22025: 1
2007high 2 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NFB

Too few NFB 510(k)s in any year since 2007 to give a median.

Recalls per year · NFB

3in 2007

2007: 3
2007high 3 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NFB

8in 2025

2007: 32011: 12012: 32013: 52014: 22015: 42017: 92020: 32021: 22022: 12023: 42024: 12025: 8
2007high 9 (2017) · low 0 (2008)2025

MAUDE reports naming product code NFB, 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
20071—33
20080—00
20091—00
20101—00
20111—01
20120—03
20131—05
20140—02
20150—04
20161—00
20170—09
20180—00
20190—00
20201—03
20210—02
20222—01
20230—04
20240—01
20251—08
20260—0—

What is it indicated for?

The Inspired Technologies 350G Gas Conserver is intended as a delivery device for medial-grade oxygen from high-pressure oxygen cylinders. This is an ambulatory device, which allows patients to ambulate longer than they would with a continuous flow regulator on the same cylinder.

The 350G Gas Conserver is intended to be used in the hospital, healthcare facilities, or home care environments.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K090421: Model 350G Gas Conserver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090421

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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