510(k) Report

510(k) · Cleared

Cleared

Zoll M Series ETCO2 Option

K993036510(k) TraditionalCleared Feb 28, 2000172-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 Feb 28, 2000 after a 172-day review. The FDA summary names no predicate by number. 304 later devices descend from it.

Decided
Feb 28, 2000
Review
172 days
Class
Class III
Product code
MKJ
Recalls
None
Predicates
0

304 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2005: 1 descendant cleared2009: 10 descendants cleared2008: 9 descendants cleared2011: 14 descendants cleared2006: 10 descendants cleared2015: 12 descendants cleared2013: 14 descendants cleared2012: 15 descendants cleared2020: 16 descendants cleared2010: 9 descendants cleared2016: 11 descendants cleared2014: 15 descendants cleared2007: 3 descendants cleared2017: 15 descendants cleared2018: 16 descendants cleared2021: 15 descendants cleared2019: 13 descendants cleared2023: 26 descendants cleared2022: 19 descendants cleared2024: 23 descendants cleared2025: 22 descendants cleared2026: 15 descendants cleared200020052010201520202025
  1. This deviceK993036 Zoll M Series ETCO2 OptionZoll Medical Corp · 2000
  2. Descendant · cites it directly · 238 of its ownK042417 Zoll M Series ETC02 Loflo OptionZoll Medical Corp · 2004
  3. Descendant · 2 generations on · 237 of its ownK053174 Loflo C5 CO2 SensorRespironics Novametrix, LLC · 2006 · Recalled
  4. Descendant · 3 generations on · 222 of its ownK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  5. Descendant · 4 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
  6. Descendant · 4 generations on · 211 of its ownK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006

Showing 5 of 304 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12006: 102007: 32008: 92009: 102010: 92011: 142012: 152013: 142014: 152015: 122016: 112017: 152018: 162019: 132020: 162021: 152022: 192023: 262024: 232025: 222026: 15
2004high 26 (2023) · low 1 (2004)2026

Most influential descendants

Showing 5 of 304 · See all
  • K042417Zoll M Series ETC02 Loflo OptionZoll Medical Corp · 2004 · cites it directly238descendants
  • K053174Loflo C5 CO2 SensorRespironics Novametrix, LLC · 2006 · 2 generations on237descendants
  • K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006 · 3 generations on222descendants
  • K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2006 · 4 generations on221descendants
  • K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc. · 2006 · 4 generations on211descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K993036Zoll M Series ETCO2 OptionZoll Medical Corp2000—
+1K042417Zoll M Series ETC02 Loflo OptionZoll Medical Corp2004—
+2K053174Loflo C5 CO2 SensorRespironics Novametrix, LLC20062
+3K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
+4K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
+4K061052The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
2006100
200730
200890
2009100
201090
2011140
2012150
2013140
2014150
2015120
2016110
2017150
2018160
2019130
2020160
2021150
2022190
2023260
2024230
2025220
2026150
FIG. 1 — Lineage of K993036, 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
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (304)

See all 304

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042417Zoll M Series ETC02 Loflo OptionZoll Medical Corp2004238
K042007Zoll E Series DefibrillatorZoll Medical Corp200564

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?

  • Of its descendants, K042417 (Zoll Medical Corp, 2004) has gone furthest, with 238 descendants of its own.

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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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
  • P160022/S056ZOLL R Series Monitor/DefibrillatorZOLL Medical Corporation · 2026
  • 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/K993036 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993036: Zoll M Series ETCO2 Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993036

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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