510(k) Report

FDA applicant

Burron Medical Products, Inc.

Mchenry, IL41 decisions1979–19875 recalls

FDA records 41 decisions for Burron Medical Products, Inc. (Mchenry, IL) from 1979 to 1987: 41 510(k) clearances. Most are in product codes BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)) and FOZ (Catheter, Intravascular, Therapeutic…). 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 Burron Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Burron Medical Products, Inc. since 2007.

Recalls per year

4in 2024

2024: 4
2007high 4 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Burron Medical Products, 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?

  • BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)4decisions
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days4decisions
  • CAZAnesthesia Conduction Kit3decisions
  • FPASet, Administration, Intravascular3decisions
  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days3decisions
  • KYXDispenser, Liquid Medication3decisions

Also: FMI (2), KRK (2), DQY (2), FMF (2), KPE (1), LJT (1).

Who builds on its devices?

Later devices cite its devices 25 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.

  • K813186Perfix Set for Epidural Anesthesia W/TuoBurron Medical Products, Inc. · 19819cite it
  • K840287Brachial Plexus Anesthesia TrayBurron Medical Products, Inc. · 19843cite it
  • K810460Burron Percutaneous Inducer SetBurron Medical Products, Inc. · 19812cite it
  • K861479Cavafix, Central Venous Catheter KitBurron Medical Products, Inc. · 19862cite it
  • K801941Burron Microcath Intra. Cath. PlacementtBurron Medical Products, Inc. · 19802cite it
  • K813179Perican, Epidural CannulaBurron Medical Products, Inc. · 19811cites it

What has FDA decided for it lately?

  • K870403Cavafix (R) Central Venous Catheter Kit W/SutureBurron Medical Products, Inc. · 1987
  • K862412IntestoplantBurron Medical Products, Inc. · 1986
  • K861479Cavafix, Central Venous Catheter KitBurron Medical Products, Inc. · 1986
  • K860126Stimuplex, Nerve StimulatorBurron Medical Products, Inc. · 19864 recalls
  • K851293ImplantofixBurron Medical Products, Inc. · 1986
  • K841428Jejunostomy Set for Tube FeedingBurron Medical Products, Inc. · 1984
  • K834383Dual-Lumen Long Term Central Venous CatBurron Medical Products, Inc. · 1984
  • K834299Long Term Central Venous Access CathBurron Medical Products, Inc. · 1984

All 41 as Burron Medical Products, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K860126Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260May 17, 2024Class II
  • K860126Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278May 17, 2024Class II
  • K860126Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.May 17, 2024Class II
  • K860126Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502May 17, 2024Class II
  • K820047Standard and Custom Spinal Trays with 5% Lidocaine Hydrochloride 2 ml ampulJul 6, 2004

Other applicant names beginning “Burron”

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

Burron Medical, Inc. 9