510(k) Report

FDA applicant

Janin Group, Inc.

Aurora, IL5 decisions1981–20021 recall

FDA records 5 decisions for Janin Group, Inc. (Aurora, IL) from 1981 to 2002: 5 510(k) clearances. Most are in product codes FJS (Catheter, Peritoneal, Long-Term Indwelling) and KQM (Camera, Surgical And Accessories). 1 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, gastroenterology and urology panel, where it files most

How often FDA has decided Janin Group, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Janin Group, Inc. since 2007.

Recalls per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Janin Group, 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?

  • FJSCatheter, Peritoneal, Long-Term Indwelling4decisions
  • KQMCamera, Surgical And Accessories1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K970159Flex-Neck PD CatheterJanin Group, Inc. · 19973cite it

What has FDA decided for it lately?

  • K012502Medigroup Catheter Extender/Repair KitJanin Group, Inc. · 2002
  • K013017Medigroup Key TubeJanin Group, Inc. · 2001
  • K991042Ash Advantage Peritoneal CatheterJanin Group, Inc. · 1999
  • K970159Flex-Neck PD CatheterJanin Group, Inc. · 19971 recall
  • K810512Mediseal Camera CoversJanin Group, Inc. · 1981

All 5 as Janin Group, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K970159Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient…Dec 20, 2017Class II