510(k) Report

FDA applicant

Metame Health, Inc.

Chicago, IL1 decision2021–20210 recalls

FDA records 1 decision for Metame Health, Inc. (Chicago, IL) in 2021: 1 510(k) clearance. All are in product code QMY (Computerized Behavioral Therapy Device For…). Its devices cite 1 predicate, 0 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2021

2021: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Metame Health, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Metame Health, 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

Which product codes does it file in?

  • QMYComputerized Behavioral Therapy Device For Treating Symptoms1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K211463ReguloraMetame Health, Inc. · 2021

The one decision as Metame Health, Inc. →