510(k) · Cleared
Recalled · Class II · 2016Purefill Oxygen Compressor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inovo, Inc. · CAW Generator, Oxygen, Portable
Cleared on Nov 7, 2014 as substantially equivalent to K091191 (Respironics Inc., Sleep & Home Respiratory Group, 2009) and 1 other predicate after a 109-day review. Its family tree reaches back 4 generations to 1997. It has been recalled once.
- Decided
- Nov 7, 2014
- Review
- 109 days
- Class
- Class II
- Product code
- CAW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K971889 (1997). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK971889 Chad Total O2 Delivery SystemChad Therapeutics, Inc. · 1997
- 3 generations backK013472 Total O2Chad Therapeutics, Inc. · 2001
- 2 generations backK053240 Devilbiss Oxygen Cylinder Filling System, 535 SeriesSunrise Medical · 2006 · Recalled
- 1 generation backK091191 Gas TransfillRespironics Inc., Sleep & Home Respiratory Group · 2009
- This deviceK141967 Purefill Oxygen CompressorInovo, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971889 | Chad Total O2 Delivery System | Chad Therapeutics, Inc. | 1997 | — |
| −3 | K013472 | Total O2 | Chad Therapeutics, Inc. | 2001 | — |
| −2 | K053240 | Devilbiss Oxygen Cylinder Filling System, 535 Series | Sunrise Medical | 2006 | 1 |
| −1 | K091191 | Gas Transfill | Respironics Inc., Sleep & Home Respiratory Group | 2009 | — |
| 0 (this device) | K141967 | Purefill Oxygen Compressor | Inovo, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K091191 | Gas TransfillSummary page 4…pressor Classification Name: Portable oxygen generator CAW – 868.5440 Predicate Devices: Gas Transfill – K091191 Home Fill II – K003939 Device Description: The PureFill Oxygen Compressor is designed to a… | 2009 |
| * | K003939 | Venture Home Fill II, Model Ioh 200Summary page 4…le oxygen generator CAW – 868.5440 Predicate Devices: Gas Transfill – K091191 Home Fill II – K003939 Device Description: The PureFill Oxygen Compressor is designed to accept low pressure (14-… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 21, 2016 | Class II | Z-0760-2017 | Under Investigation by firm | Device can fail during operation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 PureFill Oxygen Compressor is indicated to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended to be life supporting or life sustaining.
Environment of use: - Sub-acute care facilities and home settings
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141967 · printed Nov 4, 2026
Cite this page
510(k) Report. “K141967: Purefill Oxygen Compressor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K141967
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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