Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Rb Health (Us), LLC — Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

172 daysmedian FDA review time

387 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K241617	Durex Polyisoprene Condom	Rb Health (Us), LLC	2025-02-28	268	0
K230781	Belle Sensilube	Rb Health (Us), LLC	2023-06-20	90	0
K213892	Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours &	Rb Health (Us), LLC	2023-03-07	448	0
K220489	Durex Patronus CloseFit, Durex Patronus Regular	Rb Health (Us), LLC	2022-11-07	258	0
K222068	Durex Penck III Regular	Rb Health (Us), LLC	2022-10-12	90	0
K211152	Durex Condom with Benzocaine	Rb Health (Us), LLC	2022-05-11	387	0
K213647	Durex Patronus Wide	Rb Health (Us), LLC	2022-02-17	90	0
K211088	Grosz Play Feel	Rb Health (Us), LLC	2021-07-09	88	0
K200672	Durex Penck Standard, Durex Penck XL	Rb Health (Us), LLC	2020-11-06	238	0
K201186	KY Grosz Jelly	Rb Health (Us), LLC	2020-07-30	90	1
K193032	KY Grosz Liquid	Rb Health (Us), LLC	2020-04-20	172	0
K192982	KY Grosz UltraGel	Rb Health (Us), LLC	2020-04-14	172	0
K183505	KY Banksy Moisture	Rb Health (Us), LLC	2019-05-17	150	0
K183302	KY Banksy Aloe	Rb Health (Us), LLC	2019-04-16	140	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda