510(k) · Cleared
ClearedEMMA Capnograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masimo Corporation · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Mar 29, 2021 as substantially equivalent to K072813 (Phasein AB, 2007) after a 290-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Mar 29, 2021
- Review
- 290 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K935370 (1994). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK935370 Miniox IA Oxygen AnalyzerMinesafety Appliances Co. · 1994
- 4 generations backK973282 Handi Oxygen AnalyzerCeramatec, Inc. · 1998
- 3 generations backK051857 Veo Multigas Monitor for Pocket PC, Model 400221Weissburg Associates · 2005
- 2 generations backK063167 Emma Analyzer (Kpa) and (MMHG); Emma Monitor (Kpa) and (MMHG)Phasein AB · 2007
- 1 generation backK072813 Emma Analyzer (Kpa & MMHG); Emma Monitor (Kpa & MMHG)Phasein AB · 2007
- This deviceK201590 EMMA CapnographMasimo Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K935370 | Miniox IA Oxygen Analyzer | Minesafety Appliances Co. | 1994 | — |
| −4 | K973282 | Handi Oxygen Analyzer | Ceramatec, Inc. | 1998 | — |
| −3 | K051857 | Veo Multigas Monitor for Pocket PC, Model 400221 | Weissburg Associates | 2005 | — |
| −2 | K063167 | Emma Analyzer (Kpa) and (MMHG); Emma Monitor (Kpa) and (MMHG) | Phasein AB | 2007 | — |
| −1 | K072813 | Emma Analyzer (Kpa & MMHG); Emma Monitor (Kpa & MMHG) | Phasein AB | 2007 | — |
| 0 (this device) | K201590 | EMMA Capnograph | Masimo Corporation | 2021 | — |
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 |
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.
Planning a device in CCK? 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 |
|---|---|---|---|
| * | K072813 | Emma Analyzer (Kpa & MMHG); Emma Monitor (Kpa & MMHG)Summary page 4…egistration 3011353843 Number: Reason for Premarket Addition of Wireless Capabilities Notification: Predicate Device: K072813 – EMMA Emergency Capnometer Performance Standards No performance standards for the above device have been… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 9 ancestors have a recall of any class.
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. 2021, 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?
EMMA® Capnograph measures, displays and monitors carbon dioxide partial pressure and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201590: EMMA Capnograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201590
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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