510(k) Report

FDA applicant

Byron Medical

Tucson, AZ27 decisions1986–20040 recalls

FDA records 27 decisions for Byron Medical (Tucson, AZ) from 1986 to 2004: 27 510(k) clearances. Most are in product codes FWP (Prosthesis, Chin, Internal) and FRN (Pump, Infusion). Its devices cite 14 predicates, 3 of them its own earlier devices. No 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Byron Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Byron Medical 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?

  • FWPProsthesis, Chin, Internal4decisions
  • FRNPump, Infusion3decisions
  • QPBSystem, Suction, Lipoplasty For Removal3decisions
  • LZKImplant, Malar3decisions
  • FZEProsthesis, Nose, Internal3decisions
  • MIBElastomer, Silicone Block1decision

Also: BTA (1), KGX (1), KGZ (1), EME (1), GEI (1), KPE (1).

Whose devices does it build on?

Its devices cite 14 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 31 times; 3 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.

  • K981172Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and NeedlesByron Medical · 19988cite it
  • K981215Psi-Tec Liposuction AspiratorByron Medical · 19985cite it
  • K040149Psi-Tec Peristaltic Infiltration PumpByron Medical · 20044cite it
  • K973133Big Bag 3000 Pressure InfusorByron Medical · 19973cite it
  • K980392Psi-Tec AspiratorByron Medical · 19983cite it
  • K861878Byron Suction TipsByron Medical · 19863cite it

What has FDA decided for it lately?

  • K040149Psi-Tec Peristaltic Infiltration PumpByron Medical · 2004
  • K001803Accelerator Reciprocating CannulaByron Medical · 2000
  • K981215Psi-Tec Liposuction AspiratorByron Medical · 1998
  • K981172Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and NeedlesByron Medical · 1998
  • K980738Psi-Tec Syringe Infusion Pump and Accessories for General Fluid Irrigaion/InfiltrationByron Medical · 1998
  • K980392Psi-Tec AspiratorByron Medical · 1998
  • K974295Byron Medical Aspiration and Infiltration/Irrigation TubingByron Medical · 1998
  • K973133Big Bag 3000 Pressure InfusorByron Medical · 1997

All 27 as Byron Medical →