510(k) Report

FDA applicant

Medtronic Emergency Response Systems, Inc.

Redmond, WA6 decisions2004–200712 recalls

FDA records 6 decisions for Medtronic Emergency Response Systems, Inc. (Redmond, WA) from 2004 to 2007: 6 510(k) clearances. Most are in product codes MKJ (Automated External Defibrillators (Non-Wearable)) and MSX (System, Network And Communication…). Its devices cite 26 predicates, 1 of them its own earlier devices. 12 recalls are linked to its devices.

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 Emergency Response Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2020

2008: 72009: 12011: 12013: 12014: 12020: 1
2007high 7 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medtronic Emergency Response Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medtronic Emergency Response Systems…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MKJAutomated External Defibrillators (Non-Wearable)5decisions
  • MSXSystem, Network And Communication, Physiological Monitors1decision

Whose devices does it build on?

Its devices cite 26 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 1 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.

  • K041459Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 20044cite it
  • K063119Lifepak 20 Defibrillator/ MonitorMedtronic Emergency Response Systems, Inc. · 20062cite it
  • K052057Lifepak 500 Automated External DefibrillatorMedtronic Emergency Response Systems, Inc. · 20062cite it
  • K063510Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 20072cite it
  • K042404Lifepak, Model 1000Medtronic Emergency Response Systems, Inc. · 20051cites it

What has FDA decided for it lately?

  • K063510Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 20072 recalls
  • K063119Lifepak 20 Defibrillator/ MonitorMedtronic Emergency Response Systems, Inc. · 20065 recalls
  • K052057Lifepak 500 Automated External DefibrillatorMedtronic Emergency Response Systems, Inc. · 20063 recalls
  • K052854Lifenet Exchange SystemMedtronic Emergency Response Systems, Inc. · 2006
  • K042404Lifepak, Model 1000Medtronic Emergency Response Systems, Inc. · 20052 recalls
  • K041459Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2004

All 6 as Medtronic Emergency Response Systems, Inc. →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K052057LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX…Mar 20, 2020Class II
  • K042404LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode)…May 9, 2014Class II
  • K052057The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that…Jun 12, 2013Class II
  • K052057The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that…Jun 6, 2011
  • K063510Biphasic LIFEPAK 12 defibrillator / monitor.Mar 31, 2009
  • K063119Physio-Control LIFEPAK 20e defibrillator/monitor. This product is an external…May 13, 2008