510(k) Report

FDA applicant

Medtronic Physio-Control Corp.

Redmond, WA8 decisions2001–200438 recalls

FDA records 8 decisions for Medtronic Physio-Control Corp. (Redmond, WA) from 2001 to 2004: 8 510(k) clearances. Most are in product codes MKJ (Automated External Defibrillators (Non-Wearable)) and LDD (Dc-Defibrillator, Low-Energy, (Including…). Its devices cite 18 predicates, 7 of them its own earlier devices. 38 recalls are linked to its devices, 2 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Medtronic Physio-Control Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medtronic Physio-Control Corp. since 2007.

Recalls per year

3in 2020

2007: 32008: 62009: 12010: 32013: 12016: 12017: 2, 2 Class I2020: 3
2007high 6 (2008) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Medtronic Physio-Control Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MKJAutomated External Defibrillators (Non-Wearable)7decisions
  • LDDDc-Defibrillator, Low-Energy, (Including Paddles)1decision

Whose devices does it build on?

Its devices cite 18 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 39 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K033275Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 200310cite it
  • K010918Lifepak 12 Defibrillator/Monitor SystemMedtronic Physio-Control Corp. · 20017cite it
  • K002445Lifepak 12DEFIBERLLATOR/Monitor SeriesMedtronic Physio-Control Corp. · 20016cite it
  • K040775Lifepak 12Medtronic Physio-Control Corp. · 20045cite it
  • K012274Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 20024cite it
  • K022732Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 20023cite it

What has FDA decided for it lately?

  • K040775Lifepak 12Medtronic Physio-Control Corp. · 20041 recall
  • K033275Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 20031 recall
  • K022732Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 20022 Class I recalls
  • K012274Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 200217 recalls
  • K011144Lifepak 600 Automated External DefibrillatorMedtronic Physio-Control Corp. · 20019 recalls
  • K012428Modification to: Lifepak 500 Automated External DefibrillatorMedtronic Physio-Control Corp. · 20012 recalls
  • K010918Lifepak 12 Defibrillator/Monitor SystemMedtronic Physio-Control Corp. · 20014 recalls
  • K002445Lifepak 12DEFIBERLLATOR/Monitor SeriesMedtronic Physio-Control Corp. · 20011 recall

All 8 as Medtronic Physio-Control Corp. →

What has been recalled?

38 recalls linked to its devices; the latest:

  • K022732Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced…Apr 24, 2020Class II
  • K022732Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use…Apr 24, 2020Class II
  • K052057LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX…Mar 20, 2020Class II
  • K022732LIFEPAK (R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The…Oct 27, 2017Class I
  • K022732LIFEPAK (R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The…Oct 27, 2017Class I
  • K033275LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator (s) and are…May 25, 2016Class II