510(k) · Cleared
ClearedMiniox IA Oxygen Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minesafety Appliances Co. · CAW Generator, Oxygen, Portable
Cleared on Aug 2, 1994 after a 271-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 30 devices in its family, counting itself, have a Class I recall. 29 later devices descend from it.
- Decided
- Aug 2, 1994
- Review
- 271 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 0
29 later devices descend from it, 1 citing it directly. 3 of the 30 devices in this family, counting this one, have a Class I recall.
- This deviceK935370 Miniox IA Oxygen AnalyzerMinesafety Appliances Co. · 1994
- Descendant · cites it directly · 28 of its ownK973282 Handi Oxygen AnalyzerCeramatec, Inc. · 1998
- Descendant · 2 generations on · 16 of its ownK051857 Veo Multigas Monitor for Pocket PC, Model 400221Weissburg Associates · 2005
- Descendant · 3 generations on · 12 of its ownK081601 Veo Multigas Monitor for Pocket PCPhasein AB · 2008
- Descendant · 4 generations on · 11 of its ownK123043 Irma C02 Model 200101; Irma AX 200601Phasein AB · 2012
- Descendant · 2 generations on · 10 of its ownK023565 OxicheckCaradyne, Ltd. · 2003
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 29 · See all- K973282Handi Oxygen AnalyzerCeramatec, Inc. · 1998 · cites it directly28descendants
- K051857Veo Multigas Monitor for Pocket PC, Model 400221Weissburg Associates · 2005 · 2 generations on16descendants
- K081601Veo Multigas Monitor for Pocket PCPhasein AB · 2008 · 3 generations on12descendants
- K123043Irma C02 Model 200101; Irma AX 200601Phasein AB · 2012 · 4 generations on11descendants
- K023565OxicheckCaradyne, Ltd. · 2003 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935370 | Miniox IA Oxygen Analyzer | Minesafety Appliances Co. | 1994 | — |
| +1 | K973282 | Handi Oxygen Analyzer | Ceramatec, Inc. | 1998 | — |
| +2 | K051857 | Veo Multigas Monitor for Pocket PC, Model 400221 | Weissburg Associates | 2005 | — |
| +3 | K081601 | Veo Multigas Monitor for Pocket PC | Phasein AB | 2008 | — |
| +4 | K123043 | Irma C02 Model 200101; Irma AX 200601 | Phasein AB | 2012 | — |
| +2 | K023565 | Oxicheck | Caradyne, Ltd. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 2 |
| 2020 | 1 | 0 |
| 2021 | 2 | 1 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (29)
See all 291 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973282 | Handi Oxygen Analyzer | 1998 | 28 |
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 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
What does this lineage say?
- Of its descendants, K973282 (Ceramatec, Inc., 1998) has gone furthest, with 28 descendants of its own.
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 | — |
https://510kreport.com/device/K935370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935370: Miniox IA Oxygen Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935370
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026