510(k) · Cleared
Recalled · Class II · 2014Lifepak, Model 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Emergency Response Systems, Inc. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Dec 22, 2005 as substantially equivalent to K983393 (Physio-Control Corp., 1999) and 3 other predicates after a 475-day review. Its family tree reaches back 6 generations to 1993. 1 of the 26 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Dec 22, 2005
- Review
- 475 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 6 generations to K921669 (1993). 24 ancestors in all, the oldest K802288 (1980). 1 later device descends from it, 1 citing it directly. 1 of the 26 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 5 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 4 generations backK973486 Life Pak 12Physio-Control Corp. · 1998 · Recalled
- 3 generations backK991910 Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · Recalled
- 2 generations backK012274 Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · Recalled
- 1 generation backK033275 Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · Recalled
- This deviceK042404 Lifepak, Model 1000Medtronic Emergency Response Systems, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK122600 Lifepak 1000 DefibrillatorPhysio-Control, Inc. · 2012 · Recalled (Class I)
Class I recalls in this family
- K122600 Lifepak 1000 Defibrillatorcites it directly · 2012
Most influential descendants
Showing 1 of 1 · See all- K122600Lifepak 1000 DefibrillatorPhysio-Control, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −5 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −4 | K973486 | Life Pak 12 | Physio-Control Corp. | 1998 | 3 |
| −3 | K991910 | Lifepak 12 Biphasic | Physio-Control Corp. | 1999 | 3 |
| −2 | K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker | Medtronic Physio-Control Corp. | 2002 | 17 |
| −1 | K033275 | Lifepak 12, 20, 500, CR Plus | Medtronic Physio-Control Corp. | 2003 | 1 |
| 0 (this device) | K042404 | Lifepak, Model 1000 | Medtronic Emergency Response Systems, Inc. | 2005 | — |
| +1 | K122600 | Lifepak 1000 Defibrillator | Physio-Control, Inc. | 2012 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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? (4)
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 |
|---|---|---|---|
| * | K983393 | Lifepak 500 BiphasicSummary page 1…nce: The features and functions of the LIFEPAK 1000 defibrillator are substantially equivalent to the: * Medtronic LIFEPAK 500 AED, 510(k) K983393 (05/05/99) and K033275 (1 1/06/03), and * Philips HeartStart FR2+ Defibrillator with ECU Assessment Module… | 1999 |
| * | K033275 | Lifepak 12, 20, 500, CR PlusSummary page 1…tures and functions of the LIFEPAK 1000 defibrillator are substantially equivalent to the: * Medtronic LIFEPAK 500 AED, 510(k) K983393 (05/05/99) and K033275 (1 1/06/03), and * Philips HeartStart FR2+ Defibrillator with ECU Assessment Module, 5 10(k)… | 2003 |
| * | K013425 | Heartstream/Heartstart FR2 Aed Ecg Cable, Models M3860A, M3861A, M3840A, M3841ASummary page 1…, 510(k) K983393 (05/05/99) and K033275 (1 1/06/03), and * Philips HeartStart FR2+ Defibrillator with ECU Assessment Module, 5 10(k) K0 13425 (01/14/02) and K0 14157 (01/17/02). Description: The LIFEPAK 1000 defibrillator is a semi-automatic defib… | 2002 |
| * | K014157 | HEARTSTREAMFR2 Aed with M3848A and M3849A, Models M3860A, M3861, M3840A, M3841ASummary page 1…99) and K033275 (1 1/06/03), and * Philips HeartStart FR2+ Defibrillator with ECU Assessment Module, 5 10(k) K0 13425 (01/14/02) and K0 14157 (01/17/02). Description: The LIFEPAK 1000 defibrillator is a semi-automatic defibrillator with manual… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122600 | Lifepak 1000 Defibrillator Class I | 2012 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 9, 2014 | Class II | Z-1660-2014 | Software Manufacturing/Software Deployment | Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. A defibrillator in this scenario has the potential to… |
| Feb 27, 2008 | Not classified | Z-1656-2008 | Component change control | Potential for the display screen to dim and eventually go blank. The risk to patient is a delay in defibrillation therapy if the defibrillator was needed in a cardiac arrest situation. Death or permanent impairment can occur if the user… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K122600Lifepak 1000 DefibrillatorPhysio-Control, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 12 of the 24 ancestors have a recall of any class.
- Of its descendants, K122600 (Physio-Control, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K983393.
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?
Defibrillation: Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. The defibrillator may be used with standard defibrillation pads only on adults and…
Read the full statement (134 words)
Defibrillation:
Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.
The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation.
The defibrillator may be used with standard defibrillation pads only on adults and children who are 8 years old or more or who weigh more than 25 kg (551bs). The defibrillator may be used on children who are less than 8 years old or weigh less than 25 kg (55 lbs) with Infant/Child Reduced Energy Defibrillation Electrodes.
ECG Monitoring:
ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042404 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042404: Lifepak, Model 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042404
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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