510(k) Report

FDA applicant

Medefil, Inc.

Schaumburg, IL7 decisions2000–20125 recalls

FDA records 7 decisions for Medefil, Inc. (Schaumburg, IL) from 2000 to 2012: 7 510(k) clearances. Most are in product codes NGT (Saline, Vascular Access Flush) and FOZ (Catheter, Intravascular, Therapeutic…). Its devices cite 5 predicates, 5 of them its own earlier devices. 5 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2012

2010: 22012: 1
2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2022

2010: 32014: 12022: 1
2007high 3 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medefil, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medefil, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NGTSaline, Vascular Access Flush4decisions
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2decisions
  • NZWHeparin, Vascular Access Flush1decision

Who builds on its devices?

Later devices cite its devices 6 times; 5 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.

  • K020996Medefil's Heparin I.V. Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe LL; 2 ML Fill in 6 ML…Medefil, Inc. · 20022cite it
  • K993515Medefil's Normal Saline Flush Syringe, in Various Fill Sizes - 1 ML Fill in 3 ML Syringe LL; 1 ML Fill in 6…Medefil, Inc. · 20001cites it
  • K091583Medefil's Normal Saline I.V. Flush SyringeMedefil, Inc. · 20101cites it
  • K020999Medefil's Normal Saline Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe LL; 2 ML Fill in 6…Medefil, Inc. · 20021cites it
  • K993518Medefil's Heparin I.V. Flush Syringe, in Various Fill Sizes - 1 ML Fill in 3 ML Syringe LL; 1 ML Fill in 6…Medefil, Inc. · 20001cites it

What has FDA decided for it lately?

  • K121262Medeflush Normal Saline I.V. Flush Syringe-Sterile Field ReadyMedefil, Inc. · 2012
  • K092491Medefil's Heparin I.V. Flush Syringe 1 Unit/ML; 10 Units/ML; and 100 Units/ML in Various Fill SizesMedefil, Inc. · 20104 recalls
  • K091583Medefil's Normal Saline I.V. Flush SyringeMedefil, Inc. · 20101 recall
  • K020996Medefil's Heparin I.V. Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe LL; 2 ML Fill in 6 ML…Medefil, Inc. · 2002
  • K020999Medefil's Normal Saline Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe LL; 2 ML Fill in 6…Medefil, Inc. · 2002
  • K993518Medefil's Heparin I.V. Flush Syringe, in Various Fill Sizes - 1 ML Fill in 3 ML Syringe LL; 1 ML Fill in 6…Medefil, Inc. · 2000
  • K993515Medefil's Normal Saline Flush Syringe, in Various Fill Sizes - 1 ML Fill in 3 ML Syringe LL; 1 ML Fill in 6…Medefil, Inc. · 2000

All 7 as Medefil, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K091583a. Medefil Normal Saline IV Flush Syringe NORMAL SALINE FLUSH, SYR 10ML/12ML (60/BX…May 25, 2022Class II
  • K092491Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100…Feb 19, 2014Class III
  • K092491Medefil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe…Nov 1, 2010
  • K092491Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe…Nov 1, 2010
  • K092491Medefil Heparin I.V. Flush Syringe 1 units/mL; a polypropylene luer locking syringe…Nov 1, 2010