510(k) · Cleared
Recalled · 2010Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Physio-Control Corp. · LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Cleared on Feb 5, 2002 as substantially equivalent to K802288 (Stanco Medical, Inc., 1980) and 2 other predicates after a 201-day review. Its family tree reaches back 4 generations to 1993. 4 of the 39 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it. It has been recalled 17 times.
- Decided
- Feb 5, 2002
- Review
- 201 days
- Class
- Class II
- Product code
- LDD
- Recalls
- 17
- Predicates
- 3
Its longest line of descent runs back 4 generations to K921669 (1993). 17 ancestors in all, the oldest K802288 (1980). 21 later devices descend from it, 4 citing it directly. 4 of the 39 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 3 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 2 generations backK973486 Life Pak 12Physio-Control Corp. · 1998 · Recalled
- 1 generation backK991910 Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · Recalled
- This deviceK012274 Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002
- Descendant · cites it directly · 20 of its ownK033275 Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · Recalled
- Descendant · 2 generations on · 10 of its ownK040775 Lifepak 12Medtronic Physio-Control Corp. · 2004 · Recalled
- Descendant · 2 generations on · 9 of its ownK041459 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2004
- Descendant · 2 generations on · 7 of its ownK063510 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 5 of its ownK082937 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2009 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 21 · See all- K033275Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · cites it directly20descendants
- K040775Lifepak 12Medtronic Physio-Control Corp. · 2004 · 2 generations on10descendants
- K041459Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2004 · 2 generations on9descendants
- K063510Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2007 · 2 generations on7descendants
- K082937Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2009 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −3 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −2 | K973486 | Life Pak 12 | Physio-Control Corp. | 1998 | 3 |
| −1 | K991910 | Lifepak 12 Biphasic | Physio-Control Corp. | 1999 | 3 |
| 0 (this device) | K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker | Medtronic Physio-Control Corp. | 2002 | — |
| +1 | K033275 | Lifepak 12, 20, 500, CR Plus | Medtronic Physio-Control Corp. | 2003 | 1 |
| +2 | K040775 | Lifepak 12 | Medtronic Physio-Control Corp. | 2004 | 1 |
| +2 | K041459 | Lifepak 12 Defibrillator/Monitor | Medtronic Emergency Response Systems, Inc. | 2004 | — |
| +2 | K063510 | Lifepak 12 Defibrillator/Monitor | Medtronic Emergency Response Systems, Inc. | 2007 | 2 |
| +2 | K082937 | Lifepak 15 Monitor/Defibrillator | Physio-Control, Inc. | 2009 | 3 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 1 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 1 |
| 2013 | 2 | 1 |
| 2014 | 1 | 1 |
| 2015 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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.
4 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LDD device
- #1 K200849 Tempus LS - Manualscore 1.3 · 13 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K802288 | Swan Ganz Catheter Placement KitSummary page 2…and functions of the LIFEPAK 20 defibrillator/monitor are substantially equivalent to those of the Medtronic Physio-Control LIFEPAK 9P defibrillator/monitor: 510(k) no. K802288, cleared 5/21/90, and the LIFEPAK 12 defibrillator/monitor: 510(k) nos. K973486, cleared 1/9/98; and K991910, cleared 9/3/99. In… | 1980 |
| * | K973486 | Life Pak 12Summary page 2…ent to those of the Medtronic Physio-Control LIFEPAK 9P defibrillator/monitor: 510(k) no. K802288, cleared 5/21/90, and the LIFEPAK 12 defibrillator/monitor: 510(k) nos. K973486, cleared 1/9/98; and K991910, cleared 9/3/99. Indications for Use: Defibrillation is a means of terminating certain potentially… | 1998 |
| * | K991910 | Lifepak 12 BiphasicSummary page 2…Physio-Control LIFEPAK 9P defibrillator/monitor: 510(k) no. K802288, cleared 5/21/90, and the LIFEPAK 12 defibrillator/monitor: 510(k) nos. K973486, cleared 1/9/98; and K991910, cleared 9/3/99. Indications for Use: Defibrillation is a means of terminating certain potentially fatal arrhythmias, such as v… | 1999 |
What descends from it? (21)
See all 214 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 27, 2010 | Not classified | Z-1722-2011 | Device Design | A component failure on the AC power supply assembly results in "NO AC POWER" operation. A failure of AC power can result in a delay of defibrillation therapy if backup battery power is depleted. |
| May 27, 2010 | Not classified | Z-1903-2010 | Material/Component Contamination | A failure on the power supply assembly can result in either "No DC power" or "No DC or AC power." A failure of DC (battery) power can result in a delay of defibrillation therapy if no AC (line) power is available and the device will not… |
| Dec 30, 2008 | Not classified | Z-0185-2012 | Employee error | When users do not disconnect the test plug and reconnect the QUIK-COMBO electrodes to the therapy cable, the test plug signal can be misinterpreted as a patient waveform. |
| Jun 18, 2008 | Not classified | Z-2388-2008 | Nonconforming Material/Component | Potential for the coin battery to drain prematurely causing the monitor clock time and date to be incorrect and the service light indicator to illuminate. |
| Jan 8, 2008 | Not classified | Z-1050-2008 | Nonconforming Material/Component | Inoperable Device - Potential for delay in therapy or prevention of defibrillation therapy due to corrosion of the Printed Circuit Board Assemblies (PCBA). |
| Apr 27, 2007 | Not classified | Z-0925-2007 | Other | White Screen Lock up: LifePak 20 defibrillators with software version 48 or version 52 may experience an intermittent timing issue during the power on sequence. This may lock up the device resulting in the monitor screen going white, and… |
| Mar 30, 2007 | Not classified | Z-0886-2007 | Other | Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery power. |
| Aug 30, 2006 | Not classified | Z-1502-06 | Other | Devices with v38 system software do not display a ''LOW BATTERY: CONNECT TO AC POWER'' message when the monitor is on backup (DC) battery power and may shut down without warning. |
| Mar 22, 2006 | Not classified | Z-0711-06 | Nonconforming Material/Component | Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions. |
| Mar 16, 2006 | Not classified | Z-0295-2007 | Other | LIFEPAK 20 may lock-up when attempting to power-up on DC within 2 seconds after removing AC power. |
| Sep 2, 2005 | Not classified | Z-0117-06 | Other | Potential for voltage pins in connector of therapy cable to break. |
| Sep 2, 2005 | Not classified | Z-0116-06 | Other | Potential for voltage pins in connector of therapy cable to break. |
| Jun 17, 2005 | Not classified | Z-0984-05 | Other | The defibrillator may not operate if the device is turned on during an AC Loss Alert. |
| May 5, 2004 | Not classified | Z-0971-04 | Other | The DC Power Adapter may fail to charge LIFEPAK NiCd 2.4 AH batteries used with the LIFEPAK 12 defibrillator/monitor. |
| May 5, 2004 | Not classified | Z-1107-04 | Other | Therapy cable doesn't meet firm's standards/may not maintain connections sufficient to support ECG monitoring, external pacing or defibrillation; ECG connector with higher than normal connection resistance resulting in intermittent ECG… |
| Apr 5, 2004 | Not classified | Z-0938-04 | Other | Potential for display to go blank due to an electrical component that may fail due to mechanical shock of vibration of the defibrillator. |
| Nov 12, 2003 | Not classified | Z-0294-04 | Other | Device unable to recognize the connection to the hard paddles accessory. |
The 5 latest of 17 recalls; the web page lists all.
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.
- K130454Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorPhysio-Control, Inc. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K122600Lifepak 1000 DefibrillatorPhysio-Control, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K052465Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251, SPP 351Heartsine Technologies, Inc. · 2006 · 3 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 17 ancestors have a recall of any class.
- Of its descendants, K033275 (Medtronic Physio-Control Corp., 2003) has gone furthest, with 20 descendants of its own.
How does its category compare?
All LDD devicesLDD Dc-Defibrillator, Low-Energy, (Including Paddles): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDD
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LDD
124in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDD
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LDD
74in 2025
MAUDE reports naming product code LDD, 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 | 0 | — | 0 | 550 |
| 2008 | 2 | — | 11 | 1,214 |
| 2009 | 0 | — | 1 | 1,057 |
| 2010 | 2 | — | 0 | 635 |
| 2011 | 4 | 124 | 1 | 386 |
| 2012 | 0 | — | 0 | 398 |
| 2013 | 0 | — | 0 | 602 |
| 2014 | 1 | — | 2 (2) | 481 |
| 2015 | 1 | — | 0 | 86 |
| 2016 | 0 | — | 0 | 58 |
| 2017 | 0 | — | 0 | 49 |
| 2018 | 0 | — | 0 | 28 |
| 2019 | 1 | — | 0 | 34 |
| 2020 | 1 | — | 1 | 19 |
| 2021 | 1 | — | 0 | 22 |
| 2022 | 0 | — | 1 | 80 |
| 2023 | 0 | — | 0 | 264 |
| 2024 | 0 | — | 2 | 160 |
| 2025 | 0 | — | 0 | 74 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia. The biphasic waveform has only been clinically studied on adults; it has not been…
Read the full statement (147 words)
Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
The biphasic waveform has only been clinically studied on adults; it has not been studied on pediatric patients.
The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient’s ECG rhythm. In AED mode, the LIFEPAK 20 defibrillator/monitor is not intended for use on pediatric patients less than eight years old.
Noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole.
Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia.
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/K012274 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012274: Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012274
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026