510(k) Report

FDA applicant

ZOLL Medical Corporation

Chelsmford, MA69 decisions1991–202432 recalls

FDA records 69 decisions for ZOLL Medical Corporation (Chelsmford, MA) from 1991 to 2024: 63 510(k) clearances and 6 original PMA approvals. Most are in product codes MKJ (Automated External Defibrillators (Non-Wearable)) and LDD (Dc-Defibrillator, Low-Energy, (Including…). Since 2016 its 510(k)s took a median of 295 days from receipt to decision, against 203 for FDA’s reviews in the same codes and years. Its devices cite 60 predicates, 31 of them its own earlier devices. 32 recalls are linked to its devices, 1 Class I.

FDA’s records also spell it “Zoll Medical Corp”.

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’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 22008: 32009: 22010: 12011: 42012: 42013: 12014: 52015: 12017: 42018: 42021: 12024: 1
2007high 5 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

8in 2025

2008: 22009: 22010: 12011: 22014: 82017: 12019: 32023: 12024: 1, 1 Class I2025: 8
2007high 8 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • MKJAutomated External Defibrillators (Non-Wearable)39decisions
  • LDDDc-Defibrillator, Low-Energy, (Including Paddles)9decisions
  • DXJDisplay, Cathode-Ray Tube, Medical3decisions
  • DTEPulse-Generator, Pacemaker, External2decisions
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive2decisions
  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)2decisions

Also: FRN (2), CBK (2), LSZ (1), PIZ (1), MWI (1), DSK (1).

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 295 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 203 days; 0 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 60 predicates; 31 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 64 times; 31 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.

  • K042007Zoll E Series DefibrillatorZoll Medical Corp · 20059cite it
  • K032363Zoll M Series Nibp OptionZoll Medical Corp · 20036cite it
  • K033474Zoll Aed PlusZoll Medical Corp · 20045cite it
  • K060559Zoll R Series DefibrillatorZOLL Medical Corporation · 20065cite it
  • K103473Zoll Rescuenet Epcr Model Rescuenet EpcrZOLL Medical Corporation · 20113cite it
  • K110742Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation · 20113cite it

What has FDA decided for it lately?

  • K233486731 Series VentilatorZOLL Medical Corporation · 2024
  • K202375ZOLL Propaq MZOLL Medical Corporation · 2021
  • P160033Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3ZOLL Medical Corporation · 20189 recalls
  • P160034Powerheart® AED G3 ProZOLL Medical Corporation · 2018
  • K180482ZOLL Propaq MZOLL Medical Corporation · 2018
  • K172653Power InfuserZOLL Medical Corporation · 2018
  • P160022X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode…ZOLL Medical Corporation · 20171 recall
  • K162832731 Series VentilatorsZOLL Medical Corporation · 20171 Class I recall

All 36 as ZOLL Medical Corporation →All 33 as Zoll Medical Corp →

What has been recalled?

32 recalls linked to its devices; the latest:

  • P160033Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2)…Feb 13, 2025Class II
  • P160033Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2)…Feb 13, 2025Class II
  • P160033Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO…Feb 13, 2025Class II
  • P160033Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80C, (2)…Feb 13, 2025Class II
  • P160033Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2)…Feb 13, 2025Class II
  • P160033Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software…Feb 13, 2025Class II

Other applicant names beginning “ZOLL”

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

Zoll Medical Corporation, World Wide Headquarters 21Zoll Circulation, Inc. 14Zoll Manufacturing Corporation 4Zoll Respicardia, Inc. 1