510(k) Report

FDA applicant

Medtronic Andover Medical, Inc.

Haverhill, MA6 decisions1985–19911 recall

FDA records 6 decisions for Medtronic Andover Medical, Inc. (Haverhill, MA) from 1985 to 1991: 6 510(k) clearances. Most are in product codes DRX (Electrode, Electrocardiograph) and DSA (Cable, Transducer And Electrode, Patient…). 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 Medtronic Andover Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medtronic Andover Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medtronic Andover Medical, Inc. 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?

  • DRXElectrode, Electrocardiograph3decisions
  • DSACable, Transducer And Electrode, Patient, (Including Connector)1decision
  • LDDDc-Defibrillator, Low-Energy, (Including Paddles)1decision
  • GXYElectrode, Cutaneous1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K882174Modified Model 5455 Disposable Surgical CableMedtronic Andover Medical, Inc. · 19881cites it

What has FDA decided for it lately?

  • K910494Resting Ekg Electrode SeriesMedtronic Andover Medical, Inc. · 1991
  • K905446Meditronic Andover Medical Model 1690 ElectrodeMedtronic Andover Medical, Inc. · 19911 recall
  • K903018Medtronic Andover Medical Saf-D-Fib Model 1220-002Medtronic Andover Medical, Inc. · 1990
  • K903554Nortech Model 87202204 ElectrodeMedtronic Andover Medical, Inc. · 1990
  • K882174Modified Model 5455 Disposable Surgical CableMedtronic Andover Medical, Inc. · 1988
  • K852469Saf-D-FibMedtronic Andover Medical, Inc. · 1985

All 6 as Medtronic Andover Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K9054461690 Ultratrace Series ECG Electrodes, clear tape ECG electrode with wet gel. This is a…Jul 30, 2003