510(k) · Cleared
ClearedGas Transfill
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics Inc., Sleep & Home Respiratory Group · CAW Generator, Oxygen, Portable
Cleared on Oct 23, 2009 as substantially equivalent to K003939 (Invacare Corp., 2001) and 2 other predicates after a 183-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.
- Decided
- Oct 23, 2009
- Review
- 183 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K971889 (1997). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK971889 Chad Total O2 Delivery SystemChad Therapeutics, Inc. · 1997
- 2 generations backK013472 Total O2Chad Therapeutics, Inc. · 2001
- 1 generation backK053240 Devilbiss Oxygen Cylinder Filling System, 535 SeriesSunrise Medical · 2006 · Recalled
- This deviceK091191 Gas TransfillRespironics Inc., Sleep & Home Respiratory Group · 2009
- Descendant · cites it directly · 0 of its ownK141967 Purefill Oxygen CompressorInovo, Inc. · 2014 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K141967Purefill Oxygen CompressorInovo, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971889 | Chad Total O2 Delivery System | Chad Therapeutics, Inc. | 1997 | — |
| −2 | K013472 | Total O2 | Chad Therapeutics, Inc. | 2001 | — |
| −1 | K053240 | Devilbiss Oxygen Cylinder Filling System, 535 Series | Sunrise Medical | 2006 | 1 |
| 0 (this device) | K091191 | Gas Transfill | Respironics Inc., Sleep & Home Respiratory Group | 2009 | — |
| +1 | K141967 | Purefill Oxygen Compressor | Inovo, Inc. | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
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 K230052 Inogen Rove 6score 29.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003939 | Venture Home Fill II, Model Ioh 200Summary page 1…monlUsual Name Portable Oxygen generator Proprietary Name Gas Transf ill Predicate Device(s) Invacare Corp. Home Fill 1l(K003939) Chad Therapeutics Total 02 (KO1 3472) DelVilbiss Healthcare… | 2001 |
| * | K013472 | Total O2 | 2001 |
| * | K053240 | Devilbiss Oxygen Cylinder Filling System, 535 SeriesSummary page 1…vacare Corp. Home Fill 1l(K003939) Chad Therapeutics Total 02 (KO1 3472) DelVilbiss Healthcare iFill (K053240) Reason for submission new device Substantial Equivalence The Gas Transf ill issimilar to the previously clear… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141967 | Purefill Oxygen Compressor | 2014 | 0 |
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K141967 (Inovo, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K003939.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · CAW
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CAW
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAW
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · CAW
611in 2025
MAUDE reports naming product code CAW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 143 | 1 | 23 |
| 2008 | 11 | 90 | 3 | 25 |
| 2009 | 8 | 193 | 2 | 43 |
| 2010 | 5 | 133 | 0 | 48 |
| 2011 | 6 | 174 | 1 | 167 |
| 2012 | 5 | 148 | 0 | 395 |
| 2013 | 2 | — | 2 | 2,309 |
| 2014 | 6 | 277 | 2 | 24,538 |
| 2015 | 1 | — | 0 | 18,973 |
| 2016 | 1 | — | 1 | 3,167 |
| 2017 | 1 | — | 1 | 107 |
| 2018 | 3 | 203 | 0 | 116 |
| 2019 | 2 | — | 2 | 120 |
| 2020 | 5 | 224 | 1 | 125 |
| 2021 | 2 | — | 0 | 194 |
| 2022 | 4 | 458 | 2 | 305 |
| 2023 | 8 | 261 | 0 | 357 |
| 2024 | 2 | — | 5 (1) | 450 |
| 2025 | 12 | 178 | 1 | 611 |
| 2026 | 6 | 260 | 0 | — |
What is it indicated for?
The intended use of the Gas Transfill System is to provide supplemental oxygen to patients and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use.
The device is not intended to be life supporting nor life sustaining.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091191: Gas Transfill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091191
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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