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

HIL — Predicate Candidate Screening

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

49 daysmedian FDA review time

144 days90th percentile

84clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K132208	ONTEX AND OTHERS PROPRIETARY NAMES	Ontex Bvba	2014-04-10	268	0
K132819	PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS	Playtex Manufacturing, Inc.	2013-10-09	30	0
K120245	PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLID	Playtex, Inc.	2012-06-21	146	0
K111684	PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD	Playtex Manufacturing, Inc.	2012-02-03	233	0
K081555	TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENT	Procter & Gamble Co.	2008-06-27	24	1
K073662	PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPO	Playtex Products, Inc.	2008-01-17	22	0
K072376	PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS	Playtex Products, Inc.	2007-12-12	110	0
K070745	MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTL	Playtex Products, Inc.	2007-04-13	25	0
K060981	PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPO	Playtex Products, Inc.	2006-05-09	29	0
K051446	FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICAT	First Quality Hygienic, Inc.	2005-07-14	42	0
K050067	FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS	First Quality Hygienic, Inc.	2005-02-01	20	0
K042773	ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS	Rostam , Ltd.	2004-11-23	49	0
K040312	TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER	Procter & Gamble Co.	2004-05-03	84	0
K032173	FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS	First Quality Hygienic, Inc.	2003-09-03	49	0
K032080	ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS	Rostam , Ltd.	2003-08-14	38	0
K022882	MODIFICATION TO PLAYTEX TAMPONS #24002	Playtex Products, Inc.	2002-09-16	17	0
K020200	PLAYTEX DEODORANT TAMPONS, MODEL 34802	Playtex Products, Inc.	2002-03-13	50	0
K020202	PLAYTEX DEODORANT TAMPONS, MODEL 34702	Playtex Products, Inc.	2002-03-12	49	0
K020201	PLAYTEX DEODORANT TAMPONS, MODEL 34902	Playtex Products, Inc.	2002-03-12	49	0
K011996	TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR	Procter & Gamble Co.	2001-09-19	84	0
K011171	TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER	Procter & Gamble Co.	2001-07-02	76	0
K982383	PLATEX GENTLE GLIDE, SILK GLIDE, SLIMFITS, SOFT COMFORT AND	Playtex Products, Inc.	1998-08-19	42	0
K971547	PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT A	Playtex Products, Inc.	1997-06-19	52	0
K964269	PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/	Playtime Products, Inc.	1996-11-29	35	0
K961870	PLAYTEX SLIMFIT TAMPONS	Playtex Products, Inc.	1996-06-19	40	0
K961456	PLAYTEX TAMPONS #10296	Playtime Products, Inc.	1996-06-18	63	0
K953638	O.B. APPLICATOR TAMPONS	Personal Products Co.	1995-10-20	77	0
K952344	SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER P	Tambrands, Inc.	1995-07-28	70	0
K950928	ULTIMATES SILK GLIDE TAMPONS	Playtime Products, Inc.	1995-03-22	21	0
K941044	PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194	Playtex, Inc.	1994-07-27	142	0
K941196	PLATEX TAMPONS MODEL NUMBER 07094	Playtex Family Products, Inc.	1994-04-19	36	0
K940821	PLAYTEX TAMPONS #04994 UNSCENTED & SCENTED	Playtex Family Products, Inc.	1994-03-25	31	0
K932909	PLAYTEX ULTIMATES TAMPONS	Playtex Family Products, Inc.	1994-03-07	264	0
K932907	PLAYTEX ULTIMATES TAMPONS	Playtex Family Products, Inc.	1994-03-07	264	0
K934083	PLAYTEX ULTIMATES TAMPONS	Playtex Family Products, Inc.	1994-03-07	199	0
K936189	PLAYTEX ULTIMATES TAMPONS/UNSCENTED AND SCENTED	Playtex Family Products, Inc.	1994-03-07	70	0
K935276	PLAYTEX NON-DEODORANT TAMPONS, PLAYTEX DEODORANT TAMPONS	Playtex Family Products, Inc.	1994-03-07	124	0
K922834	TAMPONS, NATURAL ODOR PROT. VARIOUS ABSORBENCY	Playtex Family Products, Inc.	1993-09-01	446	0
K924279	PLAYTEX FLUSHABLE TAMPONS, REGULAR, SUPER, SUPER +	Playtex Family Products, Inc.	1993-05-21	269	0
K914438	PLAYTEX ULTIMATES UNSCENTED/SCENTED TAMPONS	Playtex Family Products, Inc.	1992-01-02	90	0
K912002	PLAYTEX NON-DEODORANT/DEODORANT TAMPONS	Playtex Family Products, Inc.	1991-08-12	98	0
K905378	PLAYTEX NON-DEODORANT AND DEODORANT TAMPONS	Playtex Family Products, Inc.	1991-02-11	73	0
K897012	SCENTED OR SCENTED DEODORIZED, UNSCENTED TAMPONS	Playtex Family Products, Inc.	1989-12-22	2	0
K896115	TAMPON, PETAL SOFT PLASTIC APPLI., DEODORANT SUPER	Tambrands, Inc.	1989-12-13	51	0
K891297	PLAYTEX PORTABLES NON-DEODORANT & DOED. TAMPONS	Playtex Family Products, Inc.	1989-06-08	87	0
K884737	PLAYTEX NON-DEODORANT AND DEODORANT TAMPONS	Playtex Family Products, Inc.	1989-01-10	57	0
K881057	PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER	Playtex, Inc.	1988-03-22	11	0
K880024	TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER PLUS	Tambrands, Inc.	1988-03-08	63	0
K880022	TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER TAMPON	Tambrands, Inc.	1988-03-02	57	0
K880023	TAMPAX COMPAK, COMPACT PLASTIC APPLI. REGU. TAMPON	Tambrands, Inc.	1988-03-02	57	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