510(k) · Cleared
ClearedEmma Analyzer (Kpa) and (MMHG); Emma Monitor (Kpa) and (MMHG)
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 Feb 6, 2007 as substantially equivalent to K963327 (Novametrix Medical Systems, Inc., 1996) and 1 other predicate after a 111-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Feb 6, 2007
- Review
- 111 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K935370 (1994). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK935370 Miniox IA Oxygen AnalyzerMinesafety Appliances Co. · 1994
- 2 generations backK973282 Handi Oxygen AnalyzerCeramatec, Inc. · 1998
- 1 generation backK051857 Veo Multigas Monitor for Pocket PC, Model 400221Weissburg Associates · 2005
- This deviceK063167 Emma Analyzer (Kpa) and (MMHG); Emma Monitor (Kpa) and (MMHG)Phasein AB · 2007
- Descendant · cites it directly · 1 of its ownK072813 Emma Analyzer (Kpa & MMHG); Emma Monitor (Kpa & MMHG)Phasein AB · 2007
- Descendant · 2 generations on · 0 of its ownK201590 EMMA CapnographMasimo Corporation · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935370 | Miniox IA Oxygen Analyzer | Minesafety Appliances Co. | 1994 | — |
| −2 | K973282 | Handi Oxygen Analyzer | Ceramatec, Inc. | 1998 | — |
| −1 | K051857 | Veo Multigas Monitor for Pocket PC, Model 400221 | Weissburg Associates | 2005 | — |
| 0 (this device) | 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 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K963327 | Tidal Wave Carbon Dioxide Monitor, Model 610Summary page 1…a. Carbon dioxide gas analyzer (21 CFR 868.1400, Product Code CCK) 7. Substantially equivalent to: a. Tidal Wave Model 610, Novametrix Medical Systems Inc. (K963327) b. VEO Multigas Monitor for Pocket PC, Phasein AB. (K051857) 8. Device description: The EMMA Emergency Capnometer is a min… | 1996 |
| * | K051857 | Veo Multigas Monitor for Pocket PC, Model 400221Summary page 1…e CCK) 7. Substantially equivalent to: a. Tidal Wave Model 610, Novametrix Medical Systems Inc. (K963327) b. VEO Multigas Monitor for Pocket PC, Phasein AB. (K051857) 8. Device description: The EMMA Emergency Capnometer is a miniature mainstream infrared gas analysis bench with an integrated… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072813 | Emma Analyzer (Kpa & MMHG); Emma Monitor (Kpa & MMHG) | 2007 | 1 |
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 13 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K072813 (Phasein AB, 2007) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K963327.
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. 2007, 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 EMMA Emergency Capnometer Monitor measures, displays and monitors carbon dioxide
concentration 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 and pediatric patients.
The EMMA Emergency Capnometer Analyzer measures and displays carbon dioxide
concentration 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 and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063167: Emma Analyzer (Kpa) and (MMHG); Emma Monitor (Kpa) and (MMHG).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063167
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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