510(k) Report

FDA applicant

Aries Medical, Inc.

Woburn, MA19 decisions1984–19910 recalls

FDA records 19 decisions for Aries Medical, Inc. (Woburn, MA) from 1984 to 1991: 19 510(k) clearances. Most are in product codes DSP (System, Balloon, Intra-Aortic And Control) and DYB (Introducer, Catheter). 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 Aries Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Aries Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Aries 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?

  • DSPSystem, Balloon, Intra-Aortic And Control8decisions
  • DYBIntroducer, Catheter4decisions
  • KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type2decisions
  • MJLEia, Blastomyces Dermatitidis1decision
  • BSOCatheter, Conduction, Anesthetic1decision
  • BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)1decision

Also: DSY (1).

Who builds on its devices?

Later devices cite its devices 5 times; 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.

  • K840202Epidural CatheterAries Medical, Inc. · 19843cite it
  • K840201Epidural Catheter TrayAries Medical, Inc. · 19841cites it
  • K840641Vessel DilatorAries Medical, Inc. · 19841cites it

What has FDA decided for it lately?

  • K912604SJM/Cad Isoflow (TM) Centrifugal Pump 2100CP, ModifAries Medical, Inc. · 1991
  • K903925Aries Meldical Model 2100HC Hank CrankAries Medical, Inc. · 1990
  • K903442Aries Taperseal (TM) SheathAries Medical, Inc. · 1990
  • K895433Aries 30CC & 50CC Intra-Aortic Balloon & Cont. SysAries Medical, Inc. · 1990
  • K882289Aries 40CC Percu. (D/L) Intra-Aortic Balloon Cath.Aries Medical, Inc. · 1988
  • K86453740CC Percutaneous Pre-Furl (D/L) Balloon CatheterAries Medical, Inc. · 1987
  • K86499440CC Per. Pre-Furl (S/L) Intra-Aortic CatheterAries Medical, Inc. · 1987
  • K86456740CC Percutaneous Furl Dou. Lumen Balloon CatheterAries Medical, Inc. · 1987

All 19 as Aries Medical, Inc. →