510(k) · Cleared
ClearedPatient Ventilation Oxygen Concentrating System, High Flow (Pvocs HF)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carleton Life Support Systems, Inc. · CAW Generator, Oxygen, Portable
Cleared on Sep 27, 2005 as substantially equivalent to K013223 (Litton Systems, Inc., 2002) after a 77-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Sep 27, 2005
- Review
- 77 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013223 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK013223 Patient Ventilation Oxygen Concentrating System (Pvocs)Litton Systems, Inc. · 2002
- This deviceK051887 Patient Ventilation Oxygen Concentrating System, High Flow (Pvocs HF)Carleton Life Support Systems, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013223 | Patient Ventilation Oxygen Concentrating System (Pvocs) | Litton Systems, Inc. | 2002 | — |
| 0 (this device) | K051887 | Patient Ventilation Oxygen Concentrating System, High Flow (Pvocs HF) | Carleton Life Support Systems, Inc. | 2005 | — |
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 |
|---|---|---|---|
| * | K013223 | Patient Ventilation Oxygen Concentrating System (Pvocs)Summary page 1…tablishment Registration Number: 3002840531 Legally Marketed Device to which Substantial Equivalence is claimed: Patient Ventilation Oxygen Concentrating System (PVOCS) K013223 Description The PVOCS HF is a dual-mode medical gas system which supplies both oxygen-enriched gas at 93 ± 3% oxygen (hereafter… | 2002 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K013223.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 PVOCS HF system is intended to provide respiratory gases to include pre and post operation respiratory oxygen, pneumatic drive gas for ventilators, and anesthesia machines, and oxygen enrichment for ventilators and anesthesia machines. It may be used in military field hospitals and other applications when oxygen stored in high pressure cylinders or liquid oxygen is not available, practical, or safe to use. It is appropriate for use by military personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051887 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051887: Patient Ventilation Oxygen Concentrating System, High Flow (Pvocs HF).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051887
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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