# Rb Health (Us), LLC

- Location (FDA's records): Parsippany, NJ
- FDA decisions: 15 (2019–2025): 15 510(k) clearances
- Names in FDA's records: Rb Health (Us), LLC (14); Rb Health (Us) (1)
- Product codes: NUC (9), HIS (5), MOL (1)
- 510(k) review time since 2016: median 145 days, against 150 for FDA's reviews in the same codes and years (9 of 14 faster)
- Predicates its devices cite: 13 (9 its own); citations of its devices by later devices: 12 (9 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Package Solutions, LLC: 1 (https://510kreport.com/company/package-solutions)
- Ansell Healthcare Products, LLC: 1 (https://510kreport.com/company/ansell-healthcare-products)
- Ssl Americas, Inc.: 1 (https://510kreport.com/company/ssl-americas)
- Reckitt Benckiser, LLC: 1 (https://510kreport.com/company/reckitt-benckiser)

## Firms that cite its devices most
- Pjur Group Luxembourg S.A.: 2 (https://510kreport.com/company/pjur-group-luxembourg)
- Ttk Healthcare Limited: 1 (https://510kreport.com/company/ttk-healthcare)

## Its most-cited devices
- K183302: KY Banksy Aloe (2019), cited by 5
- K200672: Durex Penck Standard, Durex Penck XL (2020), cited by 2
- K201186: KY Grosz Jelly (2020), cited by 1
- K211088: Grosz Play Feel (2021), cited by 1
- K211152: Durex Condom with Benzocaine (2022), cited by 1
- K183505: KY Banksy Moisture (2019), cited by 1

## Recent decisions
- K241617: Durex Polyisoprene Condom (Feb 28, 2025)
- K230781: Belle Sensilube (Jun 20, 2023)
- K213892: Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine (Mar 7, 2023)
- K220489: Durex Patronus CloseFit, Durex Patronus Regular (Nov 7, 2022)
- K222068: Durex Penck III Regular (Oct 12, 2022)
- K211152: Durex Condom with Benzocaine (May 11, 2022)
- K213400: Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry (Mar 1, 2022)
- K213647: Durex Patronus Wide (Feb 17, 2022)

Source page: https://510kreport.com/company/rb-health-us