510(k) Report

FDA applicant

Rb Health (Us), LLC

Parsippany, NJ15 decisions2019–20251 recall

FDA records 15 decisions for Rb Health (Us), LLC (Parsippany, NJ) from 2019 to 2025: 15 510(k) clearances. Most are in product codes NUC (Lubricant, Personal) and HIS (Condom). Since 2016 its 510(k)s took a median of 145 days from receipt to decision, against 150 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 9 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Rb Health (Us)”.

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 Rb Health (Us), LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019: 22020: 42021: 12022: 52023: 22025: 1
2019high 5 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2019high 1 (2022) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Rb Health (Us), LLC by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • NUCLubricant, Personal9decisions
  • HISCondom5decisions
  • MOLCondom, Synthetic1decision

How long do its 510(k) reviews take?

Since 2016, its 14 510(k)s took a median of 145 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 150 days; 9 of its 14 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 9 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.

  • K183302KY Banksy AloeRb Health (Us), LLC · 20195cite it
  • K200672Durex Penck Standard, Durex Penck XLRb Health (Us), LLC · 20202cite it
  • K201186KY Grosz JellyRb Health (Us), LLC · 20201cites it
  • K211088Grosz Play FeelRb Health (Us), LLC · 20211cites it
  • K211152Durex Condom with BenzocaineRb Health (Us), LLC · 20221cites it
  • K183505KY Banksy MoistureRb Health (Us), LLC · 20191cites it

What has FDA decided for it lately?

  • K241617Durex Polyisoprene CondomRb Health (Us), LLC · 2025
  • K230781Belle SensilubeRb Health (Us), LLC · 2023
  • K213892Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & MineRb Health (Us), LLC · 2023
  • K220489Durex Patronus CloseFit, Durex Patronus RegularRb Health (Us), LLC · 2022
  • K222068Durex Penck III RegularRb Health (Us), LLC · 2022
  • K211152Durex Condom with BenzocaineRb Health (Us), LLC · 2022
  • K213400Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play StrawberryRb Health (Us) · 2022
  • K213647Durex Patronus WideRb Health (Us), LLC · 2022

All 14 as Rb Health (Us), LLC →The one decision as Rb Health (Us) →

What has been recalled?

1 recall linked to its devices; the latest:

  • K201186KY Jelly Lubricant 2 FL OZ, Sku 901443Jun 23, 2022Class II