510(k) Report

FDA applicant

Zoll Medical Corporation, World Wide Headquarters

Chelsmford, MA21 decisions2007–20152 recalls

FDA records 21 decisions for Zoll Medical Corporation, World Wide Headquarters (Chelsmford, MA) from 2007 to 2015: 21 510(k) clearances. Most are in product codes MKJ (Automated External Defibrillators (Non-Wearable)) and LDD (Dc-Defibrillator, Low-Energy, (Including…). Its devices cite 36 predicates, 14 of them its own earlier devices. 2 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 Zoll Medical Corporation, World Wide Headquarters’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007: 22008: 22009: 32010: 32011: 52012: 42014: 12015: 1
2007high 5 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2014

2012: 12014: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Zoll Medical Corporation, World Wide Headquarters 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)17decisions
  • LDDDc-Defibrillator, Low-Energy, (Including Paddles)2decisions
  • MSXSystem, Network And Communication, Physiological Monitors1decision
  • DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)1decision

Whose devices does it build on?

Its devices cite 36 predicates; 14 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 24 times; 14 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.

  • K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 20123cite it
  • K111594Zoll E SeriesZoll Medical Corporation, World Wide Headquarters · 20113cite it
  • K110168Zoll E Series with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters · 20112cite it
  • K111296Zoll RescuenetlinkZoll Medical Corporation, World Wide Headquarters · 20112cite it
  • K072923Zoll E Series DefibrillatorZoll Medical Corporation, World Wide Headquarters · 20082cite it
  • K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters · 20122cite it

What has FDA decided for it lately?

  • K133239Zoll E SeriesZoll Medical Corporation, World Wide Headquarters · 2015
  • K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014
  • K120406Zoll Fully Automatic Aed PlusZoll Medical Corporation, World Wide Headquarters · 2012
  • K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters · 2012
  • K112761Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters · 20121 recall
  • K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 20122 recalls
  • K111296Zoll RescuenetlinkZoll Medical Corporation, World Wide Headquarters · 2011
  • K111594Zoll E SeriesZoll Medical Corporation, World Wide Headquarters · 2011

All 21 as Zoll Medical Corporation, World Wide Headquarters →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K112432Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System…Mar 5, 2014Class II
  • K112432Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by…Aug 16, 2012Class II

Other applicant names beginning “Zoll”

FDA records each applicant name separately; these may or may not be the same firm.

ZOLL Medical Corporation 69Zoll Circulation, Inc. 14Zoll Manufacturing Corporation 4Zoll Respicardia, Inc. 1