510(k) · Cleared
ClearedIsa CO2, Isa AX+, Isa or+
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 Apr 6, 2011 as substantially equivalent to K051092 (GE Healthcare, 2005) after a 118-day review. Its family tree reaches back 2 generations to 2000. 3 of the 94 devices in its family, counting itself, have a Class I recall. 91 later devices descend from it.
- Decided
- Apr 6, 2011
- Review
- 118 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001814 (2000). 91 later devices descend from it, 5 citing it directly. 3 of the 94 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK001814 Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01)…Datex-Ohmeda · 2000
- 1 generation backK051092 Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx)…GE Healthcare · 2005 · Recalled
- This deviceK103604 Isa CO2, Isa AX+, Isa or+Phasein AB · 2011
- Descendant · cites it directly · 58 of its ownK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
- Descendant · 2 generations on · 51 of its ownK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
- Descendant · 3 generations on · 24 of its ownK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
- Descendant · 3 generations on · 24 of its ownK150314 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015
- Descendant · 4 generations on · 23 of its ownK181956 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2019
Showing 5 of 91 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 91 · See all- K140188Masimo Root Monitoring SystemMasimo Corporation · 2014 · cites it directly58descendants
- K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014 · 2 generations on51descendants
- K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016 · 3 generations on24descendants
- K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015 · 3 generations on24descendants
- K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2019 · 4 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001814 | Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01) and… | Datex-Ohmeda | 2000 | — |
| −1 | K051092 | Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx… | GE Healthcare | 2005 | 2 |
| 0 (this device) | K103604 | Isa CO2, Isa AX+, Isa or+ | Phasein AB | 2011 | — |
| +1 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | — |
| +2 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | — |
| +3 | K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Masimo Corporation | 2016 | — |
| +3 | K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2015 | — |
| +4 | K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 7 | 2 |
| 2020 | 6 | 0 |
| 2021 | 3 | 1 |
| 2022 | 12 | 0 |
| 2023 | 6 | 0 |
| 2024 | 14 | 0 |
| 2025 | 13 | 0 |
| 2026 | 7 | 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? (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 |
|---|---|---|---|
| * | K051092 | Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov…Summary page 1…on Name: Multigas Monitor 6. Classification Names: Carbon-dioxide gas analyzer (21 CEFR 868.1400, Product Code CCK) 7. Substantially equivalent to: Datex-Ohmeda S/5 (K051092) 8. Device Description: ISA is a sidestreamn respiratory gas analyzer based on infrared gas spectrometry. It is intended to be… | 2005 |
What descends from it? (91)
See all 915 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 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K140188 (Masimo Corporation, 2014) has gone furthest, with 58 descendants of its own.
- 7 other devices also cite its predicate K051092.
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. 2011, 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 ISA product family consists of three types of sidestreamn gas analyzers (ISA 002, ISA AX+ and ISA OR+), intended to be connected to other medical backboard devices for monitoring of breath rate and the following breathing gases: ISA 002: 002 ISA AX+: 002, N20, Halothane, Isoflurane, Enflurane, Sevoflurane and Desfiurane ISA OR+: 002, 02, N20, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane ISA 002, ISA AX+ and ISA OR+ are intended to be…
Read the full statement (124 words)
The ISA product family consists of three types of sidestreamn gas analyzers (ISA 002, ISA AX+ and ISA OR+), intended to be connected to other medical backboard devices for monitoring of breath rate and the following breathing gases:
ISA 002: 002
ISA AX+: 002, N20, Halothane, Isoflurane, Enflurane, Sevoflurane and Desfiurane
ISA OR+: 002, 02, N20, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane
ISA 002, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The intended environment is the operating suite, intensive care unit and patient room. ISA 002 is also intended to be used in road ambulances. The intended patient population is adult, pediatric and infant patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103604: Isa CO2, Isa AX+, Isa or+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103604
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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