FDA applicant

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

Simpsonville, SC1 decision2010–20100 recalls

FDA records 1 decision for Glytec, LLC (Formally Known AS Glucotec, Inc.) (Simpsonville, SC) in 2010: 1 510(k) clearance. All are in product code NDC (Calculator, Drug Dose). 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, anesthesiology panel, where it files most

How often FDA has decided Glytec, LLC (Formally Known AS Glucotec, Inc.)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Glytec, LLC (Formally Known AS Glucotec, Inc.) by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Glytec, LLC (Formally Known AS…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Glytec”

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

Glytec, LLC 4

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

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Glytec”