510(k) Report

FDA applicant

Pharmapac, LLC

Dekalb, MS3 decisions2005–20090 recalls

FDA records 3 decisions for Pharmapac, LLC (Dekalb, MS) from 2005 to 2009: 3 510(k) clearances. All are in product code NUC (Lubricant, Personal). Its devices cite 3 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2009

2007: 12009: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pharmapac, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NUCLubricant, Personal3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K091554Pharmapac Personal LubricantPharmapac, LLC · 2009
  • K070623Pharmapac Lubricating JellyPharmapac, LLC · 2007
  • K052974Warming Liquid Personal LubricantPharmapac, LLC · 2005

All 3 as Pharmapac, LLC →