510(k) · Cleared
ClearedModification to Hiox
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sensor Medics Corp. · CBP Valve, Non-Rebreathing
Cleared on Apr 22, 2003 after a 27-day review. The FDA summary names no predicate by number. 1 of the 9 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- Apr 22, 2003
- Review
- 27 days
- Class
- Class II
- Product code
- CBP
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- This deviceK030943 Modification to HioxSensor Medics Corp. · 2003
- Descendant · cites it directly · 7 of its ownK093261 MOVESThornhill Research, Inc. · 2010 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK141460 Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2015
- Descendant · 3 generations on · 3 of its ownK160967 Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2017
- Descendant · 3 generations on · 2 of its ownK173916 Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2018
- Descendant · 2 generations on · 1 of its ownK140049 Moves SLCThornhill Research, Inc. · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K093261 MOVEScites it directly · 2010
Most influential descendants
Showing 5 of 8 · See all- K093261MOVESThornhill Research, Inc. · 2010 · cites it directly7descendants
- K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2015 · 2 generations on4descendants
- K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2017 · 3 generations on3descendants
- K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2018 · 3 generations on2descendants
- K140049Moves SLCThornhill Research, Inc. · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030943 | Modification to Hiox | Sensor Medics Corp. | 2003 | — |
| +1 | K093261 | MOVES | Thornhill Research, Inc. | 2010 | Class I |
| +2 | K141460 | Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. | 2015 | — |
| +3 | K160967 | Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. | 2017 | — |
| +3 | K173916 | Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. | 2018 | — |
| +2 | K140049 | Moves SLC | Thornhill Research, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 1 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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.
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 CBP device
- #1 K241366 QualityFlow O2 Series (QualityFLOW O2)…score 8.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093261 | MOVES Class I | 2010 | 7 |
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.
- K093261MOVESThornhill Research, Inc. · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K093261 (Thornhill Research, Inc., 2010) has gone furthest, with 7 descendants of its own.
How does its category compare?
All CBP devicesCBP Valve, Non-Rebreathing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CBP
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CBP
129in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBP
No recall names CBP since 2007.
Adverse event reports per year · CBP
1in 2021
MAUDE reports naming product code CBP, 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 | 0 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 6 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 3 | 129 | 0 | 2 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 11 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Hi-OxEO High Fi02 Mask is intended to deliver high inspired oxygen concentrations to patients who require elevated inspired oxygen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030943: Modification to Hiox.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030943
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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