510(k) · Cleared
ClearedZoll M Series with Rectilinear BI-Phasic Option (M Series BI-Phasic)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zoll Medical Corp · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Sep 3, 1999 after a 179-day review. The FDA summary names no predicate by number. 66 later devices descend from it.
- Decided
- Sep 3, 1999
- Review
- 179 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 0
66 later devices descend from it, 2 citing it directly.
- This deviceK990762 Zoll M Series with Rectilinear BI-Phasic Option (M Series BI-Phasic)Zoll Medical Corp · 1999
- Descendant · cites it directly · 64 of its ownK042007 Zoll E Series DefibrillatorZoll Medical Corp · 2005 · Recalled
- Descendant · 2 generations on · 27 of its ownK090989 Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp · 2009
- Descendant · 3 generations on · 24 of its ownK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
- Descendant · 2 generations on · 21 of its ownK060559 Zoll R Series DefibrillatorZOLL Medical Corporation · 2006 · Recalled
- Descendant · 4 generations on · 16 of its ownK171121 Masimo Root Monitoring System and AccessoriesMasimo Corporation · 2017
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 66 · See all- K042007Zoll E Series DefibrillatorZoll Medical Corp · 2005 · cites it directly64descendants
- K090989Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp · 2009 · 2 generations on27descendants
- K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016 · 3 generations on24descendants
- K060559Zoll R Series DefibrillatorZOLL Medical Corporation · 2006 · 2 generations on21descendants
- K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation · 2017 · 4 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990762 | Zoll M Series with Rectilinear BI-Phasic Option (M Series BI-Phasic) | Zoll Medical Corp | 1999 | — |
| +1 | K042007 | Zoll E Series Defibrillator | Zoll Medical Corp | 2005 | 3 |
| +2 | K090989 | Zoll R Series with Nibp and ETCO2 Options, Zoll R Series | Zoll Medical Corp | 2009 | — |
| +3 | K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Masimo Corporation | 2016 | — |
| +2 | K060559 | Zoll R Series Defibrillator | ZOLL Medical Corporation | 2006 | 1 |
| +4 | K171121 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 6 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 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
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (66)
See all 662 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K042007 (Zoll Medical Corp, 2005) has gone furthest, with 64 descendants of its own.
How does its category compare?
All MKJ devicesMKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MKJ
48in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MKJ
156in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MKJ
1in 2025
Class I (23 since 2007) Class II/III not classified
Adverse event reports per year · MKJ
13,315in 2025
MAUDE reports naming product code MKJ, 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 | 7 | 69 | 12 | 3,958 |
| 2008 | 13 | 141 | 24 | 4,752 |
| 2009 | 8 | 165 | 37 | 6,782 |
| 2010 | 4 | 250 | 35 | 7,399 |
| 2011 | 11 | 36 | 7 | 8,170 |
| 2012 | 10 | 197 | 5 (1) | 9,732 |
| 2013 | 7 | 191 | 4 | 14,955 |
| 2014 | 11 | 196 | 24 (15) | 15,399 |
| 2015 | 6 | 156 | 1 | 16,129 |
| 2016 | 0 | — | 2 (1) | 17,062 |
| 2017 | 4 | — | 6 (4) | 16,684 |
| 2018 | 20 | — | 3 | 16,591 |
| 2019 | 25 | — | 6 (2) | 16,861 |
| 2020 | 52 | — | 2 | 16,197 |
| 2021 | 41 | — | 4 | 16,300 |
| 2022 | 19 | — | 3 | 14,867 |
| 2023 | 24 | — | 11 | 13,766 |
| 2024 | 27 | — | 5 | 15,109 |
| 2025 | 48 | — | 1 | 13,315 |
| 2026 | 31 | — | 3 | — |
What is it indicated for?
The ZOLL M Series Bi-Phasic Defibrillator is to be used only by qualified medical personnel for converting ventricular fibrillation (VF), a cardiac rhythm incompatible with life, and/or Ventricular Tachycardias (VT) to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, this product is to be used in the synchronized cardioversion mode only by qualified medical personnel to terminate Atrial…
Read the full statement (278 words)
The ZOLL M Series Bi-Phasic Defibrillator is to be used only by qualified medical personnel for converting ventricular fibrillation (VF), a cardiac rhythm incompatible with life, and/or Ventricular Tachycardias (VT) to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.
In addition, this product is to be used in the synchronized cardioversion mode only by qualified medical personnel to terminate Atrial Fibrillation (AF) at lower energy and currents than monophasic defibrillators. A qualified physician must decide when synchronized cardioversion is appropriate.
In addition, this product is to be used in the synchronized cardioversion mode only by qualified medical personnel to terminate Ventricular Tachycardias (VT). A qualified physician must decide when synchronized cardioversion is appropriate.
The Rectilinear Biphasic Waveform (RBW) has been successfully tested in multi-center, prospective, randomized, transthoracic defibrillator VT/VF and AF clinical trials, and proven to defibrillate and cardiovert adult patients at lower energies and currents than existing monophasic devices. The M Series Biphasic Option incorporates some user selectable energy settings, which are lower than those used during those clinical trials. There are currently no clinical studies related to the use of the Rectilinear Biphasic Waveform (RBW) in pediatric applications. o
he-M-Sades-Riphasic-optiomisestindicatedfor direct defibrillation of the heart during open chest surgica Corocedures.
The AED or advisory function should only be used to confirm the presence of ventricular fibriltation in patients meeting the following clinical criteria:
¢ the patient should be unconscious and unresponsive
o the patient should be apneic (not breathing)
e the patient should be pulseless
Warning Do not use the unit's AED function on patients under 8 years of age. (Per AHA Guidelines for Adult Cardiopulmonary Resuscitation and AED, 3-5, 1998).
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/K990762 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990762: Zoll M Series with Rectilinear BI-Phasic Option (M Series BI-Phasic).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990762
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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