510(k) Report

FDA applicant

Gtimd, LLC

Amherst, NH3 decisions2016–20210 recalls

FDA records 3 decisions for Gtimd, LLC (Amherst, NH) from 2016 to 2021: 3 510(k) clearances. All are in product code PON (Catheter, Balloon, Dilation Of Cervical Canal). Its devices cite 4 predicates, 2 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2021

2016: 12020: 12021: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Gtimd, LLC by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PONCatheter, Balloon, Dilation Of Cervical Canal3decisions

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K160664Aqueduct 100 Cervical DilatorGtimd, LLC · 20163cite it

What has FDA decided for it lately?

  • K202433Aqueduct 200 Cervical Dilation Balloon CatheterGtimd, LLC · 2021
  • K202427Aqueduct 100 Plus Cervical Dilation Balloon CatheterGtimd, LLC · 2020
  • K160664Aqueduct 100 Cervical DilatorGtimd, LLC · 2016

All 3 as Gtimd, LLC →