510(k) · Cleared
Recalled · Class I · 2017Lifepak 1000 Defibrillator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Physio-Control, Inc. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Oct 11, 2012 as substantially equivalent to K042404 (Medtronic Emergency Response Systems, Inc., 2005) after a 45-day review. Its family tree reaches back 7 generations to 1993. 1 of the 26 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Oct 11, 2012
- Review
- 45 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 7 generations to K921669 (1993). 25 ancestors in all, the oldest K802288 (1980). No later device cites it as a predicate yet. 1 of the 26 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 6 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 5 generations backK973486 Life Pak 12Physio-Control Corp. · 1998 · Recalled
- 4 generations backK991910 Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · Recalled
- 3 generations backK012274 Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · Recalled
- 2 generations backK033275 Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · Recalled
- 1 generation backK042404 Lifepak, Model 1000Medtronic Emergency Response Systems, Inc. · 2005 · Recalled
- This deviceK122600 Lifepak 1000 DefibrillatorPhysio-Control, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −6 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −5 | K973486 | Life Pak 12 | Physio-Control Corp. | 1998 | 3 |
| −4 | K991910 | Lifepak 12 Biphasic | Physio-Control Corp. | 1999 | 3 |
| −3 | K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker | Medtronic Physio-Control Corp. | 2002 | 17 |
| −2 | K033275 | Lifepak 12, 20, 500, CR Plus | Medtronic Physio-Control Corp. | 2003 | 1 |
| −1 | K042404 | Lifepak, Model 1000 | Medtronic Emergency Response Systems, Inc. | 2005 | 2 |
| 0 (this device) | K122600 | Lifepak 1000 Defibrillator | Physio-Control, Inc. | 2012 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K042404 | Lifepak, Model 1000Summary page 2…K 1000 defibrillator are substantially equivalent to the previously cleared LIFEPAK 1000 defibrillator. The 510(k) number for the predicate LIFEPAK 1000 defibrillator is K042404 (cleared on 12/22/05). Description: The LIFPAK 1000 defibrillator is a semi-automatic defibrillator with optional manual mode a… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 13, 2017 | Class I | Z-1257-2017 | Device Design | The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 13 of the 25 ancestors have a recall of any class.
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. 2012, this device’s year, is highlighted.
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 (135 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 (55 lbs). 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K122600 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122600: Lifepak 1000 Defibrillator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122600
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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