510(k) · Cleared
ClearedO2PAK Oxygen Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pacific Precision Products · CAW Generator, Oxygen, Portable
Cleared on Jul 24, 2012 as substantially equivalent to K052396 (Oxysure Systems, Inc., 2005) after a 148-day review. Its family tree reaches back 3 generations to 1978.
- Decided
- Jul 24, 2012
- Review
- 148 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K780020 (1978). No later device cites it as a predicate yet.
- Root · 3 generations backK780020 Generator, Oxygen, PortableJet Research Center, Inc. · 1978
- 2 generations backK982243 Canogen Portable Oxygen Generator Model 615Canogen International, Ltd. · 1998
- 1 generation backK052396 Oxysure Portable Oxygen Generator, Model 615Oxysure Systems, Inc. · 2005 · Recalled
- This deviceK120566 O2PAK Oxygen GeneratorPacific Precision Products · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K780020 | Generator, Oxygen, Portable | Jet Research Center, Inc. | 1978 | — |
| −2 | K982243 | Canogen Portable Oxygen Generator Model 615 | Canogen International, Ltd. | 1998 | — |
| −1 | K052396 | Oxysure Portable Oxygen Generator, Model 615 | Oxysure Systems, Inc. | 2005 | 1 |
| 0 (this device) | K120566 | O2PAK Oxygen Generator | Pacific Precision Products | 2012 | — |
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? (1)
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 |
|---|---|---|---|
| * | K052396 | Oxysure Portable Oxygen Generator, Model 615Summary page 1…enerator, Product Code CAW PREDICATE DEVICES OxySure® Portable Oxygen Generator, Model 615, manufactured by OxySure Systems, The OxySure® FDA 5 10(k) control number is K052396. Emergency use INTENDED USE AND INDICATION FOR USE The 02PAK Portable Oxygen Generator, Model P26029 is intended to provide ox… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 34 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K052396.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 O2PAKTM Portable Oxygen Generator, Model P26029 is intended to provide oxygen for emergency use; the O2PAK TM is currently offered to be used under the Direction of trained medical military personnel in support for disaster relief, crisis response, wartime operations, deterrence and contingency operations, humanitarian relief situations or peacetime engagements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120566: O2PAK Oxygen Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120566
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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