510(k) Report

FDA applicant

Reckitt Benckiser, LLC

Parsippany, NJ9 decisions1996–20180 recalls

FDA records 9 decisions for Reckitt Benckiser, LLC (Parsippany, NJ) from 1996 to 2018: 9 510(k) clearances. Most are in product codes NUC (Lubricant, Personal) and MED (Sterilant, Medical Devices). Its devices cite 8 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Reckitt Benckiser, Inc.”, “Reckitt Benckiser”.

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 Reckitt Benckiser, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2014: 22015: 22016: 12018: 1
2007high 2 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Reckitt Benckiser, LLC’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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Which product codes does it file in?

  • NUCLubricant, Personal6decisions
  • MEDSterilant, Medical Devices2decisions
  • LRJDisinfectant, Medical Devices1decision

Whose devices does it build on?

Its devices cite 8 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 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.

  • K970230SporoxReckitt Benckiser, Inc. · 19973cite it
  • K151884K-Y Marilyn Pleasure GelReckitt Benckiser, LLC · 20162cite it
  • K140193Durex Embrace Personal LubricantReckitt Benckiser, LLC · 20141cites it
  • K173504K-Y SiliconeReckitt Benckiser, LLC · 20181cites it

What has FDA decided for it lately?

  • K173504K-Y SiliconeReckitt Benckiser, LLC · 2018
  • K151884K-Y Marilyn Pleasure GelReckitt Benckiser, LLC · 2016
  • K143532Durex SiliconeReckitt Benckiser, LLC · 2015
  • K143511K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal LubricantReckitt Benckiser · 2015
  • K131643Durex Realfeel Pleasure Gel Personal LubricantReckitt Benckiser, LLC · 2014
  • K140193Durex Embrace Personal LubricantReckitt Benckiser, LLC · 2014
  • K990703Sporox II Sterilizing & Disinfecting SolutionReckitt Benckiser, Inc. · 1999
  • K970230SporoxReckitt Benckiser, Inc. · 1997

All 5 as Reckitt Benckiser, LLC →All 3 as Reckitt Benckiser, Inc. →The one decision as Reckitt Benckiser →