510(k) Report

FDA applicant

Padpro, LLC

Deer Field, IL5 decisions2001–20029 recalls

FDA records 5 decisions for Padpro, LLC (Deer Field, IL) from 2001 to 2002: 5 510(k) clearances. All are in product code MKJ (Automated External Defibrillators (Non-Wearable)). Its devices cite 4 predicates, 1 of them its own earlier devices. 9 recalls are linked to its devices, 6 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 Padpro, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Padpro, LLC since 2007.

Recalls per year

6in 2014

2007: 22013: 12014: 6, 6 Class I
2007high 6 (2014) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Padpro, LLC’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

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K020203Padpro Model #2516Padpro, LLC · 20023cite it
  • K014209Padpro Model 2001, 2001-S, 2001-C, 2001-EpsPadpro, LLC · 20022cite it
  • K020288Padpro, Model 2603Padpro, LLC · 20021cites it

What has FDA decided for it lately?

  • K020743Padpro, Model 2502Padpro, LLC · 2002
  • K020203Padpro Model #2516Padpro, LLC · 20022 Class I recalls
  • K020288Padpro, Model 2603Padpro, LLC · 20021 Class I recall
  • K014209Padpro Model 2001, 2001-S, 2001-C, 2001-EpsPadpro, LLC · 20023 Class I recalls
  • K003548Padpro System Defibrillator Electrode AdaptersPadpro, LLC · 2001

All 5 as Padpro, LLC →

What has been recalled?

9 recalls linked to its devices; the latest:

  • K014209ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO…Nov 6, 2014Class I
  • K020203ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO…Nov 6, 2014Class I
  • K014209ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO…Nov 6, 2014Class I
  • K020203ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- COMPARABLE TO…Nov 6, 2014Class I
  • K020288PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- COMPARABLE…Nov 6, 2014Class I
  • K014209ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO…Nov 6, 2014Class I