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

HHE — Predicate Candidate Screening

16 FDA 510(k) clearances under this product code; the 50 most recent screened below.

249 daysmedian FDA review time

413 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K233361	Sunny Cup and Applicator	Menstrual Mates	2024-06-21	266
K140626	MELUNA CLASSIC/SPORT MENSTRUAL CUP	Meluna	2014-07-10	121
K121857	FEMMYCYCLE	Femcap Incorporated	2012-11-15	142
K120107	SCKOONCUP	Sckoon, Inc.	2012-09-18	249
K112165	RHEA CUP	Apex Medical Technologies, Inc.	2012-05-24	301
K092985	BELLECUP	Librette, Inc.	2010-06-28	273
K091754	LUNETTE MENSTRUAL CUP, MODELS 1 AND 2	Lune Group , Ltd.	2009-11-13	150
K070965	ALICIA MENSTRUAL CUP	Alicia International Pty , Ltd.	2008-03-05	335
K060852	MOONCUP	Mooncup Limited	2006-12-26	273
K040335	MOONCUP, STYLE A & B	Mooncup, LLC	2005-03-30	413
K021356	THE DIVACUP MENSTRUAL SOLUTION	Diva International, Inc.	2002-07-16	78
K971303	INSTEAD, SOFTCUP	Ultrafem, Inc.	1997-06-06	59
K920792	SOFTCUP(TM):2	Ultrafem, Inc.	1993-10-05	592
K910254	DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM)	CooperSurgical, Inc.	1991-04-18	86
K870803	THE KEEPER	The Keeper Co.	1987-05-06	68
K803250	TASSAWAY	Plastic Applications, Inc.	1981-02-12	51

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