510(k) Report

FDA applicant

Glytec, LLC

Greenville, SC4 decisions2012–20260 recalls

FDA records 4 decisions for Glytec, LLC (Greenville, SC) from 2012 to 2026: 4 510(k) clearances. All are in product code NDC (Calculator, Drug Dose). Since 2016 its 510(k)s took a median of 159 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 3 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2017

2012: 12017: 12026 (partial year): 2
2012high 2 (2026) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Glytec, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NDCCalculator, Drug Dose4decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 159 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K113853G+ SystemGlytec, LLC · 20125cite it
  • K152300GlucommanderGlytec, LLC · 20171cites it

What has FDA decided for it lately?

  • K261939GlucommanderGlytec, LLC · 2026
  • K254102GlucommanderGlytec, LLC · 2026
  • K152300GlucommanderGlytec, LLC · 2017
  • K113853G+ SystemGlytec, LLC · 2012

All 4 as Glytec, LLC →

Other applicant names beginning “Glytec”

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

Glytec, LLC (Formally Known AS Glucotec, Inc.) 1