510(k) Report

FDA applicant

Biowy Corporation

Lake Forest, CA3 decisions2018–20240 recalls

FDA records 3 decisions for Biowy Corporation (Lake Forest, CA) from 2018 to 2024: 3 510(k) clearances. Most are in product codes LJS (Catheter, Intravascular, Therapeutic…) and ETD (Tube, Tympanostomy). Its devices cite 3 predicates, 1 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 hospital panel, where it files most

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

FDA decisions per year

1in 2024

2018: 12020: 12024: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Biowy Corporation by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2decisions
  • ETDTube, Tympanostomy1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K173956Biowy PlCC CatheterBiowy Corporation · 20181cites it

What has FDA decided for it lately?

  • K233658Biowy Tym Tube (TT)Biowy Corporation · 2024
  • K192246Biowy PICC Catheter S KitBiowy Corporation · 2020
  • K173956Biowy PlCC CatheterBiowy Corporation · 2018

All 3 as Biowy Corporation →