FDA applicant

Arch Therapeutics, Inc.

Framingham, MA2 decisions2018–20200 recalls

FDA records 2 decisions for Arch Therapeutics, Inc. (Framingham, MA) from 2018 to 2020: 2 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). 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

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

FDA decisions per year

1in 2020

2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

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

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

See the 510(k) Report

Other applicant names beginning “Arch”

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

Arch Development Group 2 Arch Catheter, LLC 1

Arch Therapeutics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Arch”