510(k) Report

FDA applicant

Insert Molding Solutions, Inc.

Cumming, GA2 decisions2011–20180 recalls

FDA records 2 decisions for Insert Molding Solutions, Inc. (Cumming, GA) from 2011 to 2018: 2 510(k) clearances. Most are in product codes KNW (Instrument, Biopsy) and LRK (Device, Anti-Snoring). Its devices cite 4 predicates, 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 Insert Molding Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2011: 12018: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Insert Molding Solutions, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KNWInstrument, Biopsy1decision
  • LRKDevice, Anti-Snoring1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K111529Magnum Core Tissue Biopsy Needle Model MN1820, RP Cutting Needle Model RP-1820, MCN Core Tissue Biopsy…Insert Molding Solutions, Inc. · 20111cites it

What has FDA decided for it lately?

  • K172760REST EAZY ApplianceInsert Molding Solutions, Inc. · 2018
  • K111529Magnum Core Tissue Biopsy Needle Model MN1820, RP Cutting Needle Model RP-1820, MCN Core Tissue Biopsy…Insert Molding Solutions, Inc. · 2011

All 2 as Insert Molding Solutions, Inc. →