510(k) Report

FDA applicant

Medical Innovations Corp.

Milpitas, CA24 decisions1979–199518 recalls

FDA records 24 decisions for Medical Innovations Corp. (Milpitas, CA) from 1979 to 1995: 24 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and GKN (Timer, Clot, Automated). 18 recalls are linked to its devices, 2 Class I.

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

FDA decisions per year

No FDA decision for Medical Innovations Corp. since 2007.

Recalls per year

12in 2026

2011: 12021: 22024: 3, 2 Class I2026 (partial year): 12
2007high 12 (2026) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medical Innovations 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?

  • KNTTubes, Gastrointestinal (And Accessories)18decisions
  • GKNTimer, Clot, Automated1decision
  • FMFSyringe, Piston1decision
  • JAYSupport, Breathing Tube1decision
  • BTXBoard, Arm (With Cover), Sterile1decision
  • KZDInfusor, Pressure, For I.V. Bags1decision

Also: GFO (1).

Who builds on its devices?

Later devices cite its devices 7 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.

  • K922667Mic Low Profile Gastrostomy TubeMedical Innovations Corp. · 19932cite it
  • K926581Mic Transgastric Jejunal TubeMedical Innovations Corp. · 19941cites it
  • K880767Mic Needle Jejunostomy Tube KitMedical Innovations Corp. · 19881cites it
  • K924065Mic Peg TubeMedical Innovations Corp. · 19941cites it
  • K921370Mic Gastro-Enterostomy Tube ModificationMedical Innovations Corp. · 19941cites it
  • K852363Mic Gastrostomy Tube Percutaneous Insertion KitMedical Innovations Corp. · 19851cites it

What has FDA decided for it lately?

  • K945612Mic Nasogastric-Gastrojejunal Feeding TubeMedical Innovations Corp. · 1995
  • K940548Mic Percutaneous Endoscopic Jejunal Feeding TubeMedical Innovations Corp. · 1995
  • K943685Mic Disposable SnareMedical Innovations Corp. · 1994
  • K926581Mic Transgastric Jejunal TubeMedical Innovations Corp. · 1994
  • K921652Mic Transgastric Jejunal Feeding Tube KitMedical Innovations Corp. · 1994
  • K921370Mic Gastro-Enterostomy Tube ModificationMedical Innovations Corp. · 19942 Class I recalls
  • K924065Mic Peg TubeMedical Innovations Corp. · 199414 recalls
  • K922667Mic Low Profile Gastrostomy TubeMedical Innovations Corp. · 19931 recall

All 24 as Medical Innovations Corp. →

What has been recalled?

18 recalls linked to its devices; the latest:

  • K924065Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL…Apr 30, 2026Class II
  • K924065Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit…Apr 30, 2026Class II
  • K924065Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit…Apr 30, 2026Class II
  • K924065Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit…Apr 30, 2026Class II
  • K924065Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW…Apr 30, 2026Class II
  • K924065Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW…Apr 30, 2026Class II