510(k) Report

FDA applicant

Ross Product Div. Abbott Laboratories

Columbus, OH4 decisions1999–20031 recall

FDA records 4 decisions for Ross Product Div. Abbott Laboratories (Columbus, OH) from 1999 to 2003: 4 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and LZH (Pump, Infusion, Enteral). 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 Ross Product Div. Abbott Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ross Product Div. Abbott Laboratories since 2007.

Recalls per year

1in 2007

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

Class I Class II/III not classified

FIG. 1 — Ross Product Div. Abbott Laboratories 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)2decisions
  • LZHPump, Infusion, Enteral2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K992494Flexiflo Enteral Feeding TubeRoss Product Div. Abbott Laboratories · 19991cites it

What has FDA decided for it lately?

  • K031407Ross Embrace Enteral PumpRoss Product Div. Abbott Laboratories · 20031 recall
  • K003047Ambulatory Enteral Nutrition PumpRoss Product Div. Abbott Laboratories · 2001
  • K992494Flexiflo Enteral Feeding TubeRoss Product Div. Abbott Laboratories · 1999
  • K990863Modification to Flexflo Polyg Gastrostomy TubeRoss Product Div. Abbott Laboratories · 1999

All 4 as Ross Product Div. Abbott Laboratories →

What has been recalled?

1 recall linked to its devices; the latest:

  • K031407Embrace Enteral PumpJun 21, 2007

Other applicant names beginning “Ross”

FDA records each applicant name separately; these may or may not be the same firm.

Ross Products 4Ross Systems C/O Arent,Fox,Kintner,Plotkin,Kahn 2Ross Research, Inc. 2Ross Creek Medical, Inc. 1Ross Implant Technologies Corp., Inc. 1Ross Medical Technology, Inc. 1Ross Healthcare, Inc. 1