510(k) Report

FDA applicant

Birch Point Medical, Inc.

Roseville, MN1 decision2000–20003 recalls

FDA records 1 decision for Birch Point Medical, Inc. (Roseville, MN) in 2000: 1 510(k) clearance. All are in product code EGJ (Device, Iontophoresis, Other Uses). 3 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, physical medicine panel, where it files most

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

FDA decisions per year

No FDA decision for Birch Point Medical, Inc. since 2007.

Recalls per year

2in 2025

2021: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Birch Point Medical, 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?

  • EGJDevice, Iontophoresis, Other Uses1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K992708IontopatchBirch Point Medical, Inc. · 20002cite it

What has FDA decided for it lately?

  • K992708IontopatchBirch Point Medical, Inc. · 20003 recalls

The one decision as Birch Point Medical, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K992708IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch…May 22, 2025Class II
  • K992708IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is…May 22, 2025Class II
  • K992708iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System…Nov 10, 2021Class III