510(k) Report

FDA applicant

Thinx, Inc.

New York, NY1 decision2018–20180 recalls

FDA records 1 decision for Thinx, Inc. (New York, NY) in 2018: 1 510(k) clearance. All are in product code HEB (Tampon, Menstrual, Unscented). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2018

2018: 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 — Thinx, Inc. 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?

  • HEBTampon, Menstrual, Unscented1decision

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.

  • K180850re.t.a Reuseable Tampon ApplicatorThinx, Inc. · 20182cite it

What has FDA decided for it lately?

  • K180850re.t.a Reuseable Tampon ApplicatorThinx, Inc. · 2018

The one decision as Thinx, Inc. →