510(k) · Cleared
ClearedMX 300 Oxygen Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teledyne Analytical Instruments · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on Jul 17, 2003 after a 212-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 of the 18 devices in its family, counting itself, have a Class I recall. 17 later devices descend from it.
- Decided
- Jul 17, 2003
- Review
- 212 days
- Class
- Class II
- Product code
- CCL
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 1 citing it directly. 3 of the 18 devices in this family, counting this one, have a Class I recall.
- This deviceK024155 MX 300 Oxygen MonitorTeledyne Analytical Instruments · 2003
- Descendant · cites it directly · 16 of its ownK051857 Veo Multigas Monitor for Pocket PC, Model 400221Weissburg Associates · 2005
- Descendant · 2 generations on · 12 of its ownK081601 Veo Multigas Monitor for Pocket PCPhasein AB · 2008
- Descendant · 3 generations on · 11 of its ownK123043 Irma C02 Model 200101; Irma AX 200601Phasein AB · 2012
- Descendant · 3 generations on · 8 of its ownK123144 VIVO 50Ge Healthcare, Breas Medical AB · 2013 · Recalled
- Descendant · 4 generations on · 7 of its ownK160481 Vivo 60Breas Medical AB · 2016 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 17 · See all- K051857Veo Multigas Monitor for Pocket PC, Model 400221Weissburg Associates · 2005 · cites it directly16descendants
- K081601Veo Multigas Monitor for Pocket PCPhasein AB · 2008 · 2 generations on12descendants
- K123043Irma C02 Model 200101; Irma AX 200601Phasein AB · 2012 · 3 generations on11descendants
- K123144VIVO 50Ge Healthcare, Breas Medical AB · 2013 · 3 generations on8descendants
- K160481Vivo 60Breas Medical AB · 2016 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K024155 | MX 300 Oxygen Monitor | Teledyne Analytical Instruments | 2003 | — |
| +1 | K051857 | Veo Multigas Monitor for Pocket PC, Model 400221 | Weissburg Associates | 2005 | — |
| +2 | K081601 | Veo Multigas Monitor for Pocket PC | Phasein AB | 2008 | — |
| +3 | K123043 | Irma C02 Model 200101; Irma AX 200601 | Phasein AB | 2012 | — |
| +3 | K123144 | VIVO 50 | Ge Healthcare, Breas Medical AB | 2013 | 1 |
| +4 | K160481 | Vivo 60 | Breas Medical AB | 2016 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 2 |
| 2021 | 2 | 1 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have 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 CCL device
- #1 K261389 PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051857 | Veo Multigas Monitor for Pocket PC, Model 400221 | 2005 | 16 |
Has anything in its family been recalled? (3 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.
- K181170Trilogy Evo UniversalRespironics, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
What does this lineage say?
- Of its descendants, K051857 (Weissburg Associates, 2005) has gone furthest, with 16 descendants of its own.
How does its category compare?
All CCL devicesCCL Analyzer, Gas, Oxygen, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CCL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCL
Too few CCL 510(k)s in any year since 2007 to give a median.
Recalls per year · CCL
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CCL
2in 2025
MAUDE reports naming product code CCL, 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 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 2 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The MX300 is intended to continuously measure and display the concentration of oxygen in gas mixtures used in medical applications such as anesthesia, respiratory therapy, and is intended for adult, pediatric and neonatal populations.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K024155 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024155: MX 300 Oxygen Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024155
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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