510(k) Report

FDA applicant

Cardio Medical Products, Inc.

Rockaway, NJ3 decisions2011–20111 recall

FDA records 3 decisions for Cardio Medical Products, Inc. (Rockaway, NJ) in 2011: 3 510(k) clearances. All are in product code LDD (Dc-Defibrillator, Low-Energy, (Including…). Its devices cite 6 predicates, 0 of them its own earlier devices. 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 Cardio Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2011

2011: 3
2011high 3 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2011high 1 (2013) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Cardio Medical Products, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LDDDc-Defibrillator, Low-Energy, (Including Paddles)3decisions

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K103651CardiomedCardio Medical Products, Inc. · 2011
  • K103334Cardio MedCardio Medical Products, Inc. · 2011
  • K103159Cardio Med Model A102, H104, O101, P103, and Z100Cardio Medical Products, Inc. · 20111 recall

All 3 as Cardio Medical Products, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K103159Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic…Apr 26, 2013Class II