510(k) Report

FDA applicant

Sxwell USA, LLC

Iselin, NJ2 decisions2017–20180 recalls

FDA records 2 decisions for Sxwell USA, LLC (Iselin, NJ) from 2017 to 2018: 2 510(k) clearances. Most are in product codes NUC (Lubricant, Personal) and MOL (Condom, Synthetic). Its devices cite 2 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 Sxwell USA, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2017: 12018: 1
2017high 1 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Sxwell USA, LLC by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NUCLubricant, Personal1decision
  • MOLCondom, Synthetic1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K182438Synthetic Polyisoprene Lubricated Male Condom - 5 sensesSxwell USA, LLC · 2018
  • K172473LifeStyles® SKYN® Intimate Moments Personal LubricantSxwell USA, LLC · 2017

All 2 as Sxwell USA, LLC →