510(k) Report

FDA applicant

Zmi Corp.

Woburn, MA8 decisions1986–19921 recall

FDA records 8 decisions for Zmi Corp. (Woburn, MA) from 1986 to 1992: 8 510(k) clearances. Most are in product codes DRO (Pacemaker, Cardiac, External Transcutaneous…) and LDD (Dc-Defibrillator, Low-Energy, (Including…). 1 recall is 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 Zmi Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zmi Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Zmi Corp. 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?

  • DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)4decisions
  • LDDDc-Defibrillator, Low-Energy, (Including Paddles)2decisions
  • LIHInterferential Current Therapy1decision
  • DRFCatheter, Electrode Recording, Or Probe, Electrode Recording1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K915159Pediatric Multi-Function ElectrodesZmi Corp. · 19922cite it
  • K913484Zoll D-900 DefibrillatorZmi Corp. · 19911cites it

What has FDA decided for it lately?

  • K915100Brindley & Smith ET-1000Zmi Corp. · 1992
  • K915159Pediatric Multi-Function ElectrodesZmi Corp. · 19921 recall
  • K913484Zoll D-900 DefibrillatorZmi Corp. · 1991
  • K911956Zoll PD-1400 Pacer/DefibrillatorZmi Corp. · 1991
  • K895032Zoll PD 2200 Pacing-Defibrillation ElectrodesZmi Corp. · 1989
  • K885166Zmi Part NO. NTP-2100, Pediatric ElectrodesZmi Corp. · 1989
  • K873402Zoll NTP-1200 Pacer/DefibrillatorZmi Corp. · 1987
  • K855015Noninvasive Temp. Pacemaker NTP-1000Zmi Corp. · 1986

All 8 as Zmi Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K915159Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode part Number…Jul 30, 2004