Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

HHD — Predicate Candidate Screening

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

50 daysmedian FDA review time
147 days90th percentile
136clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K071827ALWAYS MENSTRUAL PADSProcter & Gamble, Inc.2007-09-20790
K012629ALWAYS DUETSProcter & Gamble Co.2001-10-05530
K003843ENVIVE MINIFORMSProcter & Gamble Co.2001-02-08580
K993870UNSCENTED INTERLABIAL MENSTRUAL PADProcter & Gamble Co.2000-01-18640
K980395GLADRAGS COTTON MENSTRUAL PADKeepers!, Inc.1998-04-16730
K953470FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTMediquip, Inc.1995-11-211200
K953668UNSCENTED ULTRATHIN MAXI PADParagon Trade Brands, Inc.1995-11-01860
K953633UNSCENTED MENSTRUAL PADTendasoft, Inc.1995-11-01890
K953667UNSCENTED CURVED ULTRATHIN MAXI PADSParagon Trade Brands, Inc.1995-11-01860
K953553UNSCENTED MENSTRAL PADParagon Trade Brands, Inc.1995-10-27910
K953517UNSCENTED MENSTRUAL PADParagon Trade Brands, Inc.1995-10-26910
K953700UNSCENTED CURVED MAXI PADParagon Trade Brands, Inc.1995-09-27500
K953666UNSCENTED MENSTRAL PAD WITH WINGSParagon Trade Brands, Inc.1995-09-27510
K953488UNSCENTED MENSTRUAL LINERParagon Trade Brands, Inc.1995-08-09150
K953487UNSCENTED MENSTRUAL SHIELDParagon Trade Brands, Inc.1995-08-09150
K951693CARESS SANITARY NAPKINSterling U.S.A., Inc.1995-07-251040
K924502REUSABLE MENSTRUAL PADKeema and Co.1994-11-308170
K942814SELF SUPER MAXI SNAITARY NAPKINSKegan & Kegan, Ltd.1994-08-05510
K940468FEMININE MAXI PADSB.A. Wholesale, Inc.1994-05-261130
K922911OPTIONS COMFORT CURVES CLOTH MENSTRUAL PAD SYSTEMFeminine Options1994-04-226740
K933950LADY'S CARE MAXI PADSLady'S Care, Inc.1994-04-132440
K935562PANTY LINERSLady'S Care, Inc.1994-04-131470
K940329NATRACARE MENSTRUAL PADSNatracare, LLC1994-04-13790
K940377UNSCENTED MENSTRUAL PAD TIER-1 REVIEWEldari, Ltd.1994-03-25580
K933879PADS MENSTRUAL, UNTREAT DEODORIZED, VARIOUS SIZESUniversal Health Care Products Canada, Inc.1994-03-242270
K934662UNSCENTED MENSTRUAL PADEldari, Ltd.1994-02-241490
K924176SABA INTIMAScott Paper Co.1993-12-234910
K924177CONFORTScott Paper , Ltd.1993-12-234910
K924175SABA CONFORTScott Paper Co.1993-12-234910
K921115ULTRA THIN MENSTRUAL PADIcd Products1993-05-214380
K925250KOTEX(R) SECUREHOLD SUPER CURVE/CURVED MAXI PADSKimberly-Clark Corp.1993-03-031380
K922575ALWAYS CONTOURS UNSCENTED MENSTRUAL PADSProcter & Gamble Co.1993-02-022460
K920830NEW FREEDOM ULTRA THIN PADSKimberly-Clark Corp.1992-09-041930
K913747STAYFREE(TM) MAXI-PADPersonal Products Co.1991-11-05760
K905178DELUXE SANITARY PADAmerican Healthcare Corp.1991-03-041050
K901690WHENEVER(R) UNSCENTED SUPER MAXI PADMarcal Paper Mills, Inc.1990-08-211330
K902160SABA CONFORT MENSTRUAL PADValle & Assoc.1990-08-21970
K902273O. B. PACK IIICustomed, Inc.1990-08-21922
K902271O. B. PACK ICustomed, Inc.1990-08-15865
K902272O. B. PACK IICustomed, Inc.1990-08-15860
K901664CAREFREE(TM) FESTIVA PANTYSHIELDSPersonal Products Co.1990-06-22730
K900421PROMISE ABSORBENT PROTECTIVE PADScott Health Care1990-06-061270
K895519SURE & NATURAL(TM) UNSCENTED MENSTRUAL PADPersonal Products Co.1989-11-29780
K894229NEW FREEDOM ANYDAY PANTILINERSKimberly-Clark Corp.1989-11-271610
K893773LAURIER SANITARY NAPKINKao Corp.1989-08-11810
K890125SANITARY NAPKIN PADSLanden Corp.1989-06-211620
K891474TAMPAX ULTRAFIT PANTY SHIELDS - MOFIFICATIONTambrands, Inc.1989-06-07830
K890654NEW FREEDOM THIN SUPER & UNSCENTED, MAXI & SUPERKimberly-Clark Corp.1989-04-25760
K884950TAMPAX ULTRAFIT PANTY SHIELDSTambrands, Inc.1989-01-10460
K884428ALWAYS UNSCENTED MENSTRUAL PADSProcter & Gamble Co.1988-12-02430

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