510(k) Report

FDA applicant

Sandoz Nutrition

Minneapolis, MN20 decisions1986–19974 recalls

FDA records 20 decisions for Sandoz Nutrition (Minneapolis, MN) from 1986 to 1997: 20 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and FPD (Tube, Feeding). Its devices cite 2 predicates, 1 of them its own earlier devices. 4 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 Sandoz Nutrition’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sandoz Nutrition since 2007.

Recalls per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Sandoz Nutrition 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)11decisions
  • FPDTube, Feeding6decisions
  • LZHPump, Infusion, Enteral3decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 1 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.

  • K940555Sandoz Nutrition Compat Enteral Feed Pump W/HydrationSandoz Nutrition · 19952cite it
  • K961664Compat Nasojejunal Feeding TubeSandoz Nutrition · 19961cites it
  • K882682Compat Enteral Delivery SystemSandoz Nutrition · 19881cites it
  • K940556Sandoz Nutrition Compat (R) Enteral Feeding PumpSandoz Nutrition · 19941cites it
  • K913407Nasojejunal Feeding Tube W/Gastric DrainageSandoz Nutrition · 19921cites it
  • K965087Compat Gastrostomy/Jejunostomy Feeding Tube Kit (088000)Sandoz Nutrition · 19971cites it

What has FDA decided for it lately?

  • K965087Compat Gastrostomy/Jejunostomy Feeding Tube Kit (088000)Sandoz Nutrition · 1997
  • K961664Compat Nasojejunal Feeding TubeSandoz Nutrition · 1996
  • K940555Sandoz Nutrition Compat Enteral Feed Pump W/HydrationSandoz Nutrition · 19951 recall
  • K940556Sandoz Nutrition Compat (R) Enteral Feeding PumpSandoz Nutrition · 19942 recalls
  • K924308Gastroport IISandoz Nutrition · 1993
  • K923983Peg Guidewire System Gastrostomy Tube KitSandoz Nutrition · 1993
  • K915308Peg Gastrostomy Tube KitSandoz Nutrition · 1993
  • K920493Peg Prep TraySandoz Nutrition · 1993

All 20 as Sandoz Nutrition →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K915439Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10…Jul 24, 2013Class II
  • K940555Compat DualFlo Enteral Delivery Pump Set with 1000-mL Twist Cap Formula Vinyl Bag and…Jan 27, 2003
  • K940556Compat 500 mL Baggle Top Fill Enteral Feeding Container with Preattached Enteral…Jan 27, 2003
  • K940556Compat Enteral Delivery Pump Set with Piercing Spike, Item number 19930700Jan 27, 2003