510(k) Report

FDA applicant

Medigroup

Mchenry, IL15 decisions1983–20123 recalls

FDA records 15 decisions for Medigroup (Mchenry, IL) from 1983 to 2012: 15 510(k) clearances. Most are in product codes FKX (System, Peritoneal, Automatic Delivery) and FJS (Catheter, Peritoneal, Long-Term Indwelling). Its devices cite 11 predicates, 4 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Medigroup, Inc.”.

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

FDA decisions per year

1in 2012

2007: 22012: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

3in 2017

2017: 3
2007high 3 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medigroup 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?

  • FKXSystem, Peritoneal, Automatic Delivery5decisions
  • FJSCatheter, Peritoneal, Long-Term Indwelling5decisions
  • HETLaparoscope, Gynecologic (And Accessories)4decisions
  • FKOCatheter, Peritoneal Dialysis, Single Use1decision

Whose devices does it build on?

Its devices cite 11 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 4 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.

  • K823331PC-204 TunnelorMedigroup · 19833cite it
  • K071167Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560Medigroup, Inc. · 20072cite it
  • K060897Embedding Tool, Model TE-1000Medigroup, Inc. · 20061cites it
  • K031351Flex-Neck PD Catheter, InfantMedigroup, Inc. · 20031cites it

What has FDA decided for it lately?

  • K120130Faller TrocarMedigroup, Inc. · 2012
  • K071167Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560Medigroup, Inc. · 2007
  • K070730Flex-Neck Arc CatheterMedigroup, Inc. · 2007
  • K060897Embedding Tool, Model TE-1000Medigroup, Inc. · 2006
  • K031351Flex-Neck PD Catheter, InfantMedigroup, Inc. · 20033 recalls
  • K974570Peritoneal Dialysis Catheter ConnectorMedigroup, Inc. · 1998
  • K823294Medigroup LS-110 Light SourceMedigroup · 1983
  • K823295Medigroup 2.2MM Needlescope Cannula&Medigroup · 1983

All 9 as Medigroup →All 6 as Medigroup, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K031351Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal…Sep 20, 2017Class II
  • K031351Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/BSep 20, 2017Class II
  • K031351Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal…Sep 20, 2017Class II