510(k) Report

FDA applicant

Medical, Inc.

Mchenry, IL29 decisions1977–20080 recalls

FDA records 29 decisions for Medical, Inc. (Mchenry, IL) from 1977 to 2008: 28 510(k) clearances and 1 original PMA approval. Most are in product codes GEX (Powered Laser Surgical Instrument) and DTM (Filter, Blood, Cardiopulmonary Bypass…). Its devices cite 19 predicates, 7 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Medical Cv, Inc.”, “The Medical Company”.

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 Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2008

2007: 12008: 2
2007high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument5decisions
  • DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line4decisions
  • JODFilter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass4decisions
  • KRJFilter, Prebypass, Cardiopulmonary Bypass3decisions
  • FJGDialyzer, Parallel Flow3decisions
  • CAKMicrofilter, Blood Transfusion2decisions

Also: CCL (2), BZC (1), FPB (1), CAI (1), OMP (1), KRH (1).

Whose devices does it build on?

Its devices cite 19 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 7 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.

  • K040744Atrilaze Soft Tissue Ablation SystemMedical Cv, Inc. · 20043cite it
  • K052495Atrilaze Malleable Ablation ProbeMedical Cv, Inc. · 20052cite it
  • K060680Atrilaze Surgical Ablation SystemMedical Cv, Inc. · 20062cite it
  • K061489Atrilaze MI Surgical Ablation SystemMedical Cv, Inc. · 20071cites it
  • K033685Northrup Universal Annuloplasty System, Model 1000Medical Cv, Inc. · 20041cites it
  • K081457Atrilaze Laser Ablation SystemMedical Cv, Inc. · 20081cites it

What has FDA decided for it lately?

  • K082311Exsudex Wound Drainage PumpThe Medical Company · 2008
  • K081457Atrilaze Laser Ablation SystemMedical Cv, Inc. · 2008
  • K061489Atrilaze MI Surgical Ablation SystemMedical Cv, Inc. · 2007
  • K060680Atrilaze Surgical Ablation SystemMedical Cv, Inc. · 2006
  • K052495Atrilaze Malleable Ablation ProbeMedical Cv, Inc. · 2005
  • K040744Atrilaze Soft Tissue Ablation SystemMedical Cv, Inc. · 2004
  • K033685Northrup Universal Annuloplasty System, Model 1000Medical Cv, Inc. · 2004
  • K926454Anesthesia Respiratory Breath Circuit Packs/ComponMedical, Inc. · 1993

All 21 as Medical, Inc. →All 7 as Medical Cv, Inc. →The one decision as The Medical Company →