510(k) Report

FDA applicant

Sentry Medical Products, Inc.

Santa Ana, CA13 decisions1983–19960 recalls

FDA records 13 decisions for Sentry Medical Products, Inc. (Santa Ana, CA) from 1983 to 1996: 13 510(k) clearances. Most are in product codes DRX (Electrode, Electrocardiograph) and GXY (Electrode, Cutaneous). No 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 Sentry Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sentry Medical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sentry Medical Products, 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, Electrocardiograph5decisions
  • GXYElectrode, Cutaneous2decisions
  • DSACable, Transducer And Electrode, Patient, (Including Connector)2decisions
  • FMTWarmer, Infant Radiant1decision
  • FOSCatheter, Umbilical Artery1decision
  • BTXBoard, Arm (With Cover), Sterile1decision

Also: JOS (1).

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.

  • K851522Diagnostic Ecg Disposable ElectrodeSentry Medical Products, Inc. · 19851cites it

What has FDA decided for it lately?

  • K962122Sentry Radiotranslucent Ecg ElectrodesSentry Medical Products, Inc. · 1996
  • K955636Sentry Disposable Dispersive ElectrodeSentry Medical Products, Inc. · 1996
  • K942827Sentry Insertion TraySentry Medical Products, Inc. · 1994
  • K934000Sentry Aqueous Gel Ecg ElectrodesSentry Medical Products, Inc. · 1994
  • K935098Baby BoardSentry Medical Products, Inc. · 1994
  • K933603LeadwireSentry Medical Products, Inc. · 1994
  • K932704Patient CableSentry Medical Products, Inc. · 1993
  • K881670Accutemp PlusSentry Medical Products, Inc. · 1988

All 13 as Sentry Medical Products, Inc. →