510(k) · Cleared
ClearedIrma C02 Model 200101; Irma AX 200601
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phasein AB · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Oct 25, 2012 as substantially equivalent to K103604 (Phasein AB, 2011) and 1 other predicate after a 27-day review. Its family tree reaches back 4 generations to 1994. 3 of the 21 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it.
- Decided
- Oct 25, 2012
- Review
- 27 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K935370 (1994). 9 ancestors in all. 11 later devices descend from it, 3 citing it directly. 3 of the 21 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK935370 Miniox IA Oxygen AnalyzerMinesafety Appliances Co. · 1994
- 3 generations backK973282 Handi Oxygen AnalyzerCeramatec, Inc. · 1998
- 2 generations backK051857 Veo Multigas Monitor for Pocket PC, Model 400221Weissburg Associates · 2005
- 1 generation backK081601 Veo Multigas Monitor for Pocket PCPhasein AB · 2008
- This deviceK123043 Irma C02 Model 200101; Irma AX 200601Phasein AB · 2012
- Descendant · cites it directly · 8 of its ownK123144 VIVO 50Ge Healthcare, Breas Medical AB · 2013 · Recalled
- Descendant · 2 generations on · 7 of its ownK160481 Vivo 60Breas Medical AB · 2016 · Recalled
- Descendant · 3 generations on · 5 of its ownK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- Descendant · 3 generations on · 2 of its ownK193586 Vivo 45 LSBreas Medical AB · 2021 · Recalled (Class I)
- Descendant · 4 generations on · 0 of its ownK232365 Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 11 · See all- K123144VIVO 50Ge Healthcare, Breas Medical AB · 2013 · cites it directly8descendants
- K160481Vivo 60Breas Medical AB · 2016 · 2 generations on7descendants
- K181166Trilogy EvoRespironics, Inc. · 2019 · 3 generations on5descendants
- K193586Vivo 45 LSBreas Medical AB · 2021 · 3 generations on2descendants
- K232365Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935370 | Miniox IA Oxygen Analyzer | Minesafety Appliances Co. | 1994 | — |
| −3 | K973282 | Handi Oxygen Analyzer | Ceramatec, Inc. | 1998 | — |
| −2 | K051857 | Veo Multigas Monitor for Pocket PC, Model 400221 | Weissburg Associates | 2005 | — |
| −1 | K081601 | Veo Multigas Monitor for Pocket PC | Phasein AB | 2008 | — |
| 0 (this device) | K123043 | Irma C02 Model 200101; Irma AX 200601 | Phasein AB | 2012 | — |
| +1 | K123144 | VIVO 50 | Ge Healthcare, Breas Medical AB | 2013 | 1 |
| +2 | K160481 | Vivo 60 | Breas Medical AB | 2016 | 2 |
| +3 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
| +3 | K193586 | Vivo 45 LS | Breas Medical AB | 2021 | Class I |
| +4 | K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 2 |
| 2021 | 1 | 1 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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.
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 CCK device
- #1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K103604 | Isa CO2, Isa AX+, Isa or+Summary page 1…fication Names: Carbon-dioxide gas analyzer (21 CIFR 868.1400, Product Code CCK) 7. Substantially equivalent to: ISA (Infrared Sidestreamn Gas Analyzer, K1 03604) VEO Multigas Monitor for Pocket PC (K081601) 8. Device Description: IRMA isa mainstream respiratory gas analyzer based… | 2011 |
| * | K081601 | Veo Multigas Monitor for Pocket PCSummary page 1…868.1400, Product Code CCK) 7. Substantially equivalent to: ISA (Infrared Sidestreamn Gas Analyzer, K1 03604) VEO Multigas Monitor for Pocket PC (K081601) 8. Device Description: IRMA isa mainstream respiratory gas analyzer based on infrared gas spectrometry. It is intended… | 2008 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K123144 (Ge Healthcare, Breas Medical AB, 2013) has gone furthest, with 8 descendants of its own.
- 4 other devices also cite its predicate K103604.
How does its category compare?
All CCK devicesCCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · CCK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCK
169in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CCK
1in 2022
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · CCK
1,259in 2025
MAUDE reports naming product code CCK, 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 | 5 | 56 | 0 | 7 |
| 2008 | 3 | 248 | 1 | 20 |
| 2009 | 3 | 101 | 19 | 21 |
| 2010 | 3 | 125 | 4 | 12 |
| 2011 | 2 | — | 14 | 18 |
| 2012 | 7 | 150 | 3 | 13 |
| 2013 | 4 | 132 | 2 (1) | 28 |
| 2014 | 9 | 166 | 0 | 51 |
| 2015 | 5 | 105 | 1 | 114 |
| 2016 | 2 | — | 0 | 88 |
| 2017 | 5 | 134 | 0 | 58 |
| 2018 | 6 | 296 | 5 | 63 |
| 2019 | 7 | 261 | 7 (7) | 141 |
| 2020 | 4 | 188 | 1 | 2,302 |
| 2021 | 4 | 227 | 0 | 2,272 |
| 2022 | 3 | 226 | 1 | 2,475 |
| 2023 | 4 | 555 | 0 | 1,637 |
| 2024 | 3 | 592 | 0 | 1,216 |
| 2025 | 3 | 169 | 0 | 1,259 |
| 2026 | 3 | 224 | 0 | — |
What is it indicated for?
The IRMA mainstream gas analyzer is intended to be connected to other medical devices for monitoring of breath rate and the breathing gases C02, N20 and the anesthetic agents Halothane, Enflurane, Isoflurane, Sevoflurane and Desfiurane. It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit and…
Read the full statement (109 words)
The IRMA mainstream gas analyzer is intended to be connected to other medical devices for monitoring of breath rate and the breathing gases C02, N20 and the anesthetic agents Halothane, Enflurane, Isoflurane, Sevoflurane and Desfiurane.
It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit and patient room for adult, pediatric and infant patients. IRMA C02 may also be used in the emergency medical services environment and road ambulances.
Note: An IRMA mainstream gas analyzer shall only be connected to medical backboard devices approved by PHASEIN.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123043: Irma C02 Model 200101; Irma AX 200601.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123043
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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