510(k) Report

FDA applicant

Survivalink Corp.

Minnetonka, MN7 decisions1995–20024 recalls

FDA records 7 decisions for Survivalink Corp. (Minnetonka, MN) from 1995 to 2002: 7 510(k) clearances. Most are in product codes MKJ (Automated External Defibrillators (Non-Wearable)) and LDD (Dc-Defibrillator, Low-Energy, (Including…). Its devices cite 7 predicates, 3 of them its own earlier devices. 4 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 Survivalink Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Survivalink Corp. since 2007.

Recalls per year

2in 2008

2008: 2
2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Survivalink Corp.’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)6decisions
  • LDDDc-Defibrillator, Low-Energy, (Including Paddles)1decision

Whose devices does it build on?

Its devices cite 7 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 3 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.

  • K011901Firstsave Star Biphasic, Model 9210/9200Survivalink Corp. · 20023cite it
  • K010214Firstsave Biphasic Model #9200 and 9210Survivalink Corp. · 20012cite it
  • K971149SVL-9130 Defibrillation ElectrodeSurvivalink Corp. · 19972cite it
  • K982264Firstsave Biphasic Models 9200 and 9210Survivalink Corp. · 19992cite it
  • K970481V2Survivalink Corp. · 19971cites it
  • K940445Vivalink Aed DefibrillatorSurvivalink Corp. · 19951cites it

What has FDA decided for it lately?

  • K011901Firstsave Star Biphasic, Model 9210/9200Survivalink Corp. · 20022 recalls
  • K010214Firstsave Biphasic Model #9200 and 9210Survivalink Corp. · 20011 recall
  • K993072Survivalink Multifunctional Electrode (SVL-9630)Survivalink Corp. · 1999
  • K982264Firstsave Biphasic Models 9200 and 9210Survivalink Corp. · 1999
  • K970481V2Survivalink Corp. · 1997
  • K971149SVL-9130 Defibrillation ElectrodeSurvivalink Corp. · 19971 recall
  • K940445Vivalink Aed DefibrillatorSurvivalink Corp. · 1995

All 7 as Survivalink Corp. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K9711499051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System…Jan 23, 2008
  • K010214Electrode Adaptor Cable Quick-Combo System, Model 9055 The 9055 Electrode Adaptor is…Jan 23, 2008
  • K011901Power Heart AED Automatic External Defibrillator, Model 9200 RDMay 24, 2004
  • K011901Power Heart Automatic External Defibrillator, Model 9210 RDMay 24, 2004