510(k) Report

510(k) · Cleared

Cleared

Zoll M Series ETC02 Loflo Option

K042417510(k) SpecialCleared Oct 5, 200428-day reviewClass III21 CFR 870.5310

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Zoll Medical Corp · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on Oct 5, 2004 as substantially equivalent to K993036 (Zoll Medical Corp, 2000) and 1 other predicate after a 28-day review. Its family tree reaches back 3 generations to 2000. 238 later devices descend from it.

Decided
Oct 5, 2004
Review
28 days
Class
Class III
Product code
MKJ
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K001359 (2000). 4 ancestors in all, the oldest K993036 (2000). 238 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2006: 9 descendants cleared2015: 8 descendants cleared2013: 13 descendants cleared2012: 10 descendants cleared2020: 10 descendants cleared2007: 3 descendants cleared2009: 5 descendants cleared2011: 9 descendants cleared2008: 5 descendants cleared2010: 6 descendants cleared2016: 10 descendants cleared2018: 14 descendants cleared2014: 9 descendants cleared2017: 12 descendants cleared2021: 13 descendants cleared2019: 10 descendants cleared2023: 22 descendants cleared2022: 18 descendants cleared2025: 21 descendants cleared2024: 18 descendants cleared2026: 13 descendants clearedK001359 · Dash 3000/4000 Patient Monitor · General Electric Medical Systems Information Techn · 2000 · recalledK020290 · Dash 3000/4000 Patient Monitor · General Electric Medical Systems Information Techn · 2002 · recalledK030431 · Modification to Dash 3000/4000 Patient Monitor · Ge Medical Systems Information Technologies · 2003 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 7 descendants3 generations forward: 25 descendants4 generations forward: 31 descendants5 generations forward: 45 descendants6 generations forward: 38 descendants7 generations forward: 40 descendants8 generations forward: 26 descendants9 generations forward: 12 descendants10 generations forward: 7 descendants11 generations forward: 6 descendants K030431 · Modification to Dash 3000/4000 Patient Monitor · Ge Medical Systems Information Technologies · 2003 · recalledK020290 · Dash 3000/4000 Patient Monitor · General Electric Medical Systems Information Techn · 2002 · recalledK001359 · Dash 3000/4000 Patient Monitor · General Electric Medical Systems Information Techn · 2000 · recalled0+5+10
  1. Root · 3 generations backK001359 Dash 3000/4000 Patient MonitorGeneral Electric Medical Systems Information Techn · 2000 · Recalled
  2. 2 generations backK020290 Dash 3000/4000 Patient MonitorGeneral Electric Medical Systems Information Techn · 2002 · Recalled
  3. 1 generation backK030431 Modification to Dash 3000/4000 Patient MonitorGe Medical Systems Information Technologies · 2003 · Recalled
  4. This deviceK042417 Zoll M Series ETC02 Loflo OptionZoll Medical Corp · 2004
  5. Descendant · cites it directly · 237 of its ownK053174 Loflo C5 CO2 SensorRespironics Novametrix, LLC · 2006 · Recalled
  6. Descendant · 2 generations on · 222 of its ownK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  7. Descendant · 3 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
  8. Descendant · 3 generations on · 211 of its ownK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
  9. Descendant · 3 generations on · 188 of its ownK062283 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90…Philips Medical Systems North America, Inc. · 2006

Showing 5 of 238 descendants. See all descendants

Descendants cleared per year

2006: 92007: 32008: 52009: 52010: 62011: 92012: 102013: 132014: 92015: 82016: 102017: 122018: 142019: 102020: 102021: 132022: 182023: 222024: 182025: 212026: 13
2006high 22 (2023) · low 3 (2007)2026

Most influential descendants

Showing 5 of 238 · See all
  • K053174Loflo C5 CO2 SensorRespironics Novametrix, LLC · 2006 · cites it directly237descendants
  • K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006 · 2 generations on222descendants
  • K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2006 · 3 generations on221descendants
  • K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc. · 2006 · 3 generations on211descendants
  • K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc. · 2006 · 3 generations on188descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K001359Dash 3000/4000 Patient MonitorGeneral Electric Medical Systems Information Techn20001
−2K020290Dash 3000/4000 Patient MonitorGeneral Electric Medical Systems Information Techn20021
−1K030431Modification to Dash 3000/4000 Patient MonitorGe Medical Systems Information Technologies20031
0 (this device)K042417Zoll M Series ETC02 Loflo OptionZoll Medical Corp2004—
+1K053174Loflo C5 CO2 SensorRespironics Novametrix, LLC20062
+2K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
+3K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
+3K061052The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc.2006—
+3K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient…Philips Medical Systems North America, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200690
200730
200850
200950
201060
201190
2012100
2013130
201490
201580
2016100
2017120
2018140
2019100
2020100
2021130
2022180
2023220
2024180
2025210
2026130
FIG. 1 — Lineage of K042417, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 MKJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K993036Zoll M Series ETCO2 Option
Summary page 1
…6 Date Summary Prepared: August 24, 2004 Device: ZOLL M Series EtCO2 LoFIoTM Option Classification: The previously approved EtCO2 Option (K993036) was established as a Class III device due to its combination with the ZOLL Defibrillator/Pacer/Monitor, which…
Zoll Medical Corp2000—
*K030431Modification to Dash 3000/4000 Patient Monitor
Summary page 2
…to the current features and functions of the EtCO2 Option (K993036), cleared for use on 2/28/2000 and the GE Medical Systems Dash 3000/4000 Patient Monitor (K030431), cleared for use on 2/26/2003. Intended Use: The ZOLL M Series EtCO2 LoFIoTM Option is indicated for the continuou…
Ge Medical Systems Information Technologies20031

Also cleared against K993036: 1 other device →

What descends from it? (238)

See all 238

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K053174Loflo C5 CO2 SensorRespironics Novametrix, LLC2006237

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 4 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
  • 3 of the 4 ancestors have a recall of any class.
  • Of its descendants, K053174 (Respironics Novametrix, LLC, 2006) has gone furthest, with 237 descendants of its own.
  • 1 other device also cites its predicate K993036.

How does its category compare?

All MKJ devices

MKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MKJ

48in 2025

2007: 72008: 132009: 82010: 42011: 112012: 102013: 72014: 112015: 62017: 42018: 202019: 252020: 522021: 412022: 192023: 242024: 272025: 482026 (partial year): 31
2007high 52 (2020) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MKJ

156in 2015

2007: 69 days median2008: 141 days median2009: 165 days median2010: 250 days median2011: 36 days median2012: 197 days median2013: 191 days median2014: 196 days median2015: 156 days median
2007high 250 (2010) · low 36 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MKJ

1in 2025

2007: 122008: 242009: 372010: 352011: 72012: 5, 1 Class I2013: 42014: 24, 15 Class I2015: 12016: 2, 1 Class I2017: 6, 4 Class I2018: 32019: 6, 2 Class I2020: 22021: 42022: 32023: 112024: 52025: 12026 (partial year): 3
2007high 37 (2009) · low 1 (2015)2026

Class I (23 since 2007) Class II/III not classified

Adverse event reports per year · MKJ

13,315in 2025

2007: 3,9582008: 4,7522009: 6,7822010: 7,3992011: 8,1702012: 9,7322013: 14,9552014: 15,3992015: 16,1292016: 17,0622017: 16,6842018: 16,5912019: 16,8612020: 16,1972021: 16,3002022: 14,8672023: 13,7662024: 15,1092025: 13,315
2007high 17,062 (2016) · low 3,958 (2007)2025

MAUDE reports naming product code MKJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007769123,958
200813141244,752
20098165376,782
20104250357,399
2011113678,170
2012101975 (1)9,732
20137191414,955
20141119624 (15)15,399
20156156116,129
20160—2 (1)17,062
20174—6 (4)16,684
201820—316,591
201925—6 (2)16,861
202052—216,197
202141—416,300
202219—314,867
202324—1113,766
202427—515,109
202548—113,315
202631—3—

What is it indicated for?

The ZOLL M Series EtCO2 Option with Respironics Novametrix technology and Capnostat® sensor is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in patients requiring ventilator support, transport, and anesthesia. The M Series EtCO2 Option is designed to monitor adult, pediatric, and neonatal patients.

Indications for use as stated in the FDA summary.

Also cleared against K993036

1 other device cites the same predicate.

  • K042007Zoll E Series DefibrillatorZoll Medical Corp · 20053 recalls

More from Zoll Medical Corp

33 FDA decisions under this applicant name. See the company

  • K133484Zoll X SeriesZoll Medical Corp · 2014
  • K112660PocketcprZoll Medical Corp · 2012
  • K090989Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp · 2009
  • K042007Zoll E Series DefibrillatorZoll Medical Corp · 20053 recalls
  • K042302Zoll Autoclavable Internal Handles, Zoll Autoclavable Internal Handles with Integrated Electrodes, Zoll…Zoll Medical Corp · 2004

Recent decisions in MKJ

The MKJ category page

  • P160015/S029AED 3 Defibrillator with Uni-PadzZOLL Medical Corporation · 2026
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  • P160022/S054X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode…ZOLL Medical Corporation · 2026
  • P160026/S074Lifepak 1000 Defibrillator, Lifepak 20 Defibrillator/ Monitor, Lifepak 20E Defibrillator/ Monitor, Lifepak…Physio-Control, Inc. · 2026
  • P160026/S073LIFEPAK® 15 monitor/defibrillatorPhysio-Control, Inc. · 2026

https://510kreport.com/device/K042417 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042417: Zoll M Series ETC02 Loflo Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042417

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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