510(k) · Cleared
Recalled · 2009Loflo C5 CO2 Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics Novametrix, LLC · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Jan 12, 2006 as substantially equivalent to K042417 (Zoll Medical Corp, 2004) after a 59-day review. Its family tree reaches back 4 generations to 2000. 237 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 12, 2006
- Review
- 59 days
- Class
- Class II
- Product code
- CCK
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001359 (2000). 5 ancestors in all, the oldest K993036 (2000). 237 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK001359 Dash 3000/4000 Patient MonitorGeneral Electric Medical Systems Information Techn · 2000 · Recalled
- 3 generations backK020290 Dash 3000/4000 Patient MonitorGeneral Electric Medical Systems Information Techn · 2002 · Recalled
- 2 generations backK030431 Modification to Dash 3000/4000 Patient MonitorGe Medical Systems Information Technologies · 2003 · Recalled
- 1 generation backK042417 Zoll M Series ETC02 Loflo OptionZoll Medical Corp · 2004
- This deviceK053174 Loflo C5 CO2 SensorRespironics Novametrix, LLC · 2006
- Descendant · cites it directly · 222 of its ownK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- Descendant · 2 generations on · 221 of its ownK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
- Descendant · 2 generations on · 211 of its ownK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
- Descendant · 2 generations on · 188 of its ownK062283 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90…Philips Medical Systems North America, Inc. · 2006
- Descendant · 2 generations on · 176 of its ownK062392 Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006
Showing 5 of 237 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 237 · See all- K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006 · cites it directly222descendants
- K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2006 · 2 generations on221descendants
- K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc. · 2006 · 2 generations on211descendants
- K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc. · 2006 · 2 generations on188descendants
- K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006 · 2 generations on176descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001359 | Dash 3000/4000 Patient Monitor | General Electric Medical Systems Information Techn | 2000 | 1 |
| −3 | K020290 | Dash 3000/4000 Patient Monitor | General Electric Medical Systems Information Techn | 2002 | 1 |
| −2 | K030431 | Modification to Dash 3000/4000 Patient Monitor | Ge Medical Systems Information Technologies | 2003 | 1 |
| −1 | K042417 | Zoll M Series ETC02 Loflo Option | Zoll Medical Corp | 2004 | — |
| 0 (this device) | K053174 | Loflo C5 CO2 Sensor | Respironics Novametrix, LLC | 2006 | — |
| +1 | K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| +2 | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… | Philips Medizin Systeme Boblingen GmbH | 2006 | 2 |
| +2 | K061052 | The Philips Intellivue Patient Monitors, Models… | Philips Medical Systems North America, Inc. | 2006 | — |
| +2 | K062283 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient… | Philips Medical Systems North America, Inc. | 2006 | — |
| +2 | K062392 | Philips MP5 Intellivue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 8 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 9 | 0 |
| 2012 | 10 | 0 |
| 2013 | 13 | 0 |
| 2014 | 9 | 0 |
| 2015 | 8 | 0 |
| 2016 | 10 | 0 |
| 2017 | 12 | 0 |
| 2018 | 14 | 0 |
| 2019 | 10 | 0 |
| 2020 | 10 | 0 |
| 2021 | 13 | 0 |
| 2022 | 18 | 0 |
| 2023 | 22 | 0 |
| 2024 | 18 | 0 |
| 2025 | 21 | 0 |
| 2026 | 13 | 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 |
|---|---|---|---|
| * | K042417 | Zoll M Series ETC02 Loflo OptionSummary page 1…mon Name: C0 2 sensor Classification Name: Class II,21 C.FR 868.1400 Predicate Device: Zoll M Series EtCO 2 LoFlo Option [510(k) K042417] Description of Device: The LoFlo C5 CO2 sensor is designed for continuous, non-invasive sidestream… | 2004 |
What descends from it? (237)
See all 2377 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient… | 2006 | 222 |
| K113833 | Vital Signs Monitor | 2012 | 3 |
| K062095 | Mcare 300 Vital Signs Monitor, Model 91220 | 2006 | 3 |
| K131586 | Canary Breathing System | 2013 | 2 |
| K192488 | CO2 Sidestream Module | 2020 | 0 |
| K142244 | Cleo Patient Monitor | 2015 | 0 |
| K123797 | NT1D Vital Signs Monitor | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 19, 2009 | Not classified | Z-1264-2010 | Nonconforming Material/Component | Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may… |
| Nov 19, 2009 | Not classified | Z-1265-2010 | Nonconforming Material/Component | Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K060221 (Philips Medizin Systeme Boeblingen GmbH, 2006) has gone furthest, with 222 descendants of its own.
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.
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 intended use of the LoFlo C5 C0 2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053174: Loflo C5 CO2 Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053174
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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