510(k) Report

FDA applicant

International Medsurg Connection

Schaumburg, IL13 decisions1997–201160 recalls

FDA records 13 decisions for International Medsurg Connection (Schaumburg, IL) from 1997 to 2011: 13 510(k) clearances. Most are in product codes KKX (Drape, Surgical, Antimicrobial) and FMF (Syringe, Piston). Its devices cite 14 predicates, 2 of them its own earlier devices. 60 recalls are linked to its devices.

FDA’s records also spell it “International Medsurg Connection, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided International Medsurg Connection’s devices, and how often a recall has named them.

FDA decisions per year

3in 2011

2010: 42011: 3
2007high 4 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2022

2017: 582022: 2
2007high 58 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — International Medsurg Connection 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?

  • KKXDrape, Surgical, Antimicrobial5decisions
  • FMFSyringe, Piston3decisions
  • FMINeedle, Hypodermic, Single Lumen2decisions
  • FXXMask, Surgical1decision
  • LJHSystem, Irrigation, Urological1decision
  • MMPCover, Barrier, Protective1decision

Whose devices does it build on?

Its devices cite 14 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 2 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.

  • K102584Imc Hypodermic NeedleInternational Medsurg Connection · 20114cite it
  • K100846Imc Surgical Face MaskInternational Medsurg Connection · 20103cite it
  • K052169Imc Surgical DrapesInternational Medsurg Connection, Inc. · 20052cite it
  • K022159Piston Syringe & Hypodermic NeedleInternational Medsurg Connection · 20021cites it
  • K014239Medsurg Equipment CoversInternational Medsurg Connection · 20021cites it
  • K102969Imc Piston SyringesInternational Medsurg Connection · 20101cites it

What has FDA decided for it lately?

  • K110882Imc Insulin SyringeInternational Medsurg Connection · 2011
  • K110656Imc Blood Collection NeedleInternational Medsurg Connection · 2011
  • K102584Imc Hypodermic NeedleInternational Medsurg Connection · 201120 recalls
  • K102969Imc Piston SyringesInternational Medsurg Connection · 201040 recalls
  • K100991Imc Surgical DrapeInternational Medsurg Connection · 2010
  • K100846Imc Surgical Face MaskInternational Medsurg Connection · 2010
  • K100208Imc Surgical DrapeInternational Medsurg Connection · 2010
  • K052169Imc Surgical DrapesInternational Medsurg Connection, Inc. · 2005

All 11 as International Medsurg Connection →All 2 as International Medsurg Connection, Inc. →

What has been recalled?

60 recalls linked to its devices; the latest:

  • K102969HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care…Dec 15, 2022Class II
  • K102969HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care…Dec 15, 2022Class II
  • K102969Piston Syringe, 10 CC L/S, 100 per box, 12 boxes/case, 1,200/case The products are used…Jun 23, 2017Class II
  • K102584Hypodermic Needle, 27 G X 1.5 in HYPODERMIC, 100 per box, 50 boxes/case, 5,000/case The…Jun 23, 2017Class II
  • K102584Hypodermic Needle, 20 G X 1.5 in BD YALE DISP RG, 100 per box, 50 boxes/case, 5,000/case…Jun 23, 2017Class II
  • K102584Hypodermic Needle, 19 G X 1.5 in BD YALE DISP RG, 100 per box, 50 boxes/case, 5,000/case…Jun 23, 2017Class II