510(k) Report

FDA applicant

Ross Research, Inc.

Mchenry, IL2 decisions1982–19840 recalls

FDA records 2 decisions for Ross Research, Inc. (Mchenry, IL) from 1982 to 1984: 2 510(k) clearances. All are in product code DRO (Pacemaker, Cardiac, External Transcutaneous…). 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 Ross Research, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ross Research, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ross Research, 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?

  • DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)2decisions

What has FDA decided for it lately?

  • K840353Pacemaker Pulse Generator W/ElectrodeRoss Research, Inc. · 1984
  • K822246Noninvasive Temporary PacemakerRoss Research, Inc. · 1982

All 2 as Ross Research, Inc. →

Other applicant names beginning “Ross”

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

Ross Products 4Ross Product Div. Abbott Laboratories 4Ross Systems C/O Arent,Fox,Kintner,Plotkin,Kahn 2Ross Creek Medical, Inc. 1Ross Implant Technologies Corp., Inc. 1Ross Medical Technology, Inc. 1Ross Healthcare, Inc. 1