510(k) Report

FDA applicant

Medisystems Corp.

Mchenry, IL22 decisions1981–20073 recalls

FDA records 22 decisions for Medisystems Corp. (Mchenry, IL) from 1981 to 2007: 22 510(k) clearances. Most are in product codes FIE (Needle, Fistula) and KOC (Accessories, Blood Circuit, Hemodialysis). Its devices cite 10 predicates, 5 of them its own earlier devices. 3 recalls are linked to its devices.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Medisystems Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

3in 2012

2012: 3
2007high 3 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • FIENeedle, Fistula6decisions
  • KOCAccessories, Blood Circuit, Hemodialysis5decisions
  • FIBProtector, Transducer, Dialysis3decisions
  • FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve2decisions
  • FMINeedle, Hypodermic, Single Lumen2decisions
  • FPASet, Administration, Intravascular2decisions

Also: KDJ (1), FJI (1).

Whose devices does it build on?

Its devices cite 10 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 19 times; 5 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.

  • K932074Medisystems Apheresis Needle with GuardMedisystems Corp. · 19944cite it
  • K990803Medisystems Buttonhole Needle SetsMedisystems Corp. · 20004cite it
  • K953823Arterial Venous Blood Tubing SetMedisystems Corp. · 19963cite it
  • K994306ReversoMedisystems Corp. · 20002cite it
  • K895856Medisystems Transducer ProtectorMedisystems Corp. · 19892cite it
  • K823068Medisystems Fistula NeedlesMedisystems Corp. · 19831cites it

What has FDA decided for it lately?

  • K062953Medisystems Arterial-Venous Fistula Needle Set with Securement DeviceMedisystems Corp. · 2007
  • K010279Medisystems Luer Access Injection SiteMedisystems Corp. · 2001
  • K002372Access Alert GaugeMedisystems Corp. · 2000
  • K994306ReversoMedisystems Corp. · 2000
  • K990803Medisystems Buttonhole Needle SetsMedisystems Corp. · 20001 recall
  • K983076Medisystems Transducer ProtectorMedisystems Corp. · 1998
  • K971860Medisystems Dialysis Priming SetsMedisystems Corp. · 1997
  • K963668Medisystems Peritoneal Dialysis SetsMedisystems Corp. · 1997

All 22 as Medisystems Corp. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K990803Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product…Dec 20, 2012Class II
  • K910734Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product…Dec 20, 2012Class II
  • K910734Medisystems (a Nxstage Company) Hemodialysis Fistula Needle Set with MasterGuard…Jan 31, 2012