510(k) Report

FDA applicant

Argon Medical Corp.

Mchenry, IL28 decisions1976–201319 recalls

FDA records 28 decisions for Argon Medical Corp. (Mchenry, IL) from 1976 to 2013: 28 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and DQO (Catheter, Intravascular, Diagnostic). Its devices cite 3 predicates, 0 of them its own earlier devices. 19 recalls are linked to its devices, 2 Class I.

FDA’s records also spell it “Argon Medical”.

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

FDA decisions per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2026

2009: 12010: 92016: 12018: 12020: 42022: 12026 (partial year): 2, 2 Class I
2007high 9 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Argon Medical Corp. 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?

  • DYBIntroducer, Catheter5decisions
  • DQOCatheter, Intravascular, Diagnostic3decisions
  • JCYCatheter, Infusion2decisions
  • DWONeedle, Biopsy, Cardiovascular1decision
  • KODCatheter, Urological1decision
  • FPKTubing, Fluid Delivery1decision

Also: DXT (1), KGZ (1), KNZ (1), DQR (1), FKG (1), GDY (1).

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 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.

  • K841926Hydroglide Spring Guide WiresArgon Medical Corp. · 19852cite it
  • K853312Argon Cut Biopsy Needles, Various SizesArgon Medical Corp. · 19851cites it
  • K871297Kadir HI-Torque Guide WireArgon Medical Corp. · 19871cites it
  • K891022Introducer for Ptca Guiding CathetersArgon Medical Corp. · 19891cites it
  • K884375Translumbar Aortography Needle CatheterArgon Medical Corp. · 19891cites it
  • K780126Dilator, Vessel & Introducer, SheathArgon Medical Corp. · 19781cites it

What has FDA decided for it lately?

  • K130730V-Stick Vascular Access SetArgon Medical · 2013
  • K904994Closed System Flush SetArgon Medical Corp. · 1991
  • K895511Catheter Balloon Dilator Pressure GaugeArgon Medical Corp. · 1990
  • K894157ObturatorArgon Medical Corp. · 1989
  • K891022Introducer for Ptca Guiding CathetersArgon Medical Corp. · 1989
  • K884375Translumbar Aortography Needle CatheterArgon Medical Corp. · 1989
  • K882221Over the Needle Catheter, Arterial Catheter NeedleArgon Medical Corp. · 1988
  • K871297Kadir HI-Torque Guide WireArgon Medical Corp. · 1987

All 27 as Argon Medical Corp. →The one decision as Argon Medical →

What has been recalled?

19 recalls linked to its devices; the latest:

  • K780871Arterial Line Kit 20ga x 6, REF: 400115AJun 1, 2026Class I
  • K780126One-Piece Introducer Tray, REF: 497455, 497434 cardiovascularJun 1, 2026Class I
  • K7808711. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"Jan 24, 2022Class II
  • K780126ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO…Jun 19, 2020Class II
  • K780871Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 -…Apr 8, 2020Class II
  • K780126PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI…Apr 8, 2020Class II

Other applicant names beginning “Argon”

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

Argon Medical Devices, Inc. 25Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG 4