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

Kimberly-Clark Corp. — Predicate Candidate Screening

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

57 daysmedian FDA review time

193 days90th percentile

104clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K140963	KIMGUARD SMART-FOLD STERILIZATION WRAP	Kimberly-Clark Corp.	2014-11-10	209	0
K141294	U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS	Kimberly-Clark Corp.	2014-08-25	98	0
K131879	KC 300 SURGICAL MASK	Kimberly-Clark Corp.	2013-12-20	179	1
K131841	KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE	Kimberly-Clark Corp.	2013-11-07	139	0
K131254	KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE	Kimberly-Clark Corp.	2013-08-20	110	5
K120985	KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING	Kimberly-Clark Corp.	2012-12-19	261	0
K112805	KIMGUARD ONE-STEP STERILIZATION WRAP	Kimberly-Clark Corp.	2012-06-22	269	0
K113423	KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDE	Kimberly-Clark Corp.	2012-03-09	109	0
K112300	KIMGUARD SMART-FOLD* STERILIZATION WRAP	Kimberly-Clark Corp.	2012-01-19	162	0
K112635	U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS	Kimberly-Clark Corp.	2011-10-07	28	0
K110455	KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS	Kimberly-Clark Corp.	2011-04-29	73	0
K103406	MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS	Kimberly-Clark Corp.	2010-12-23	34	2
K102666	KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVE	Kimberly-Clark Corp.	2010-11-09	55	0
K102032	KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM	Kimberly-Clark Corp.	2010-09-08	51	0
K093115	KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100	Kimberly-Clark Corp.	2010-03-19	168	0
K091749	U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGUL	Kimberly-Clark Corp.	2009-12-23	190	0
K093312	KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY F	Kimberly-Clark Corp.	2009-12-08	47	0
K092167	KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, K	Kimberly-Clark Corp.	2009-11-02	104	0
K091685	KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, K	Kimberly-Clark Corp.	2009-09-03	85	0
K091357	MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400	Kimberly-Clark Corp.	2009-08-10	94	2
K082554	KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC4	Kimberly-Clark Corp.	2009-05-01	240	0
K082177	KIMGUARD ONE-STEP STERILIZATION WRAP	Kimberly-Clark Corp.	2009-03-27	238	0
K083234	KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY	Kimberly-Clark Corp.	2009-03-25	142	2
K080795	ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN	Kimberly-Clark Corp.	2008-09-03	167	0
K081089	KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE E	Kimberly-Clark Corp.	2008-07-14	89	0
K081260	KIMBERLY-CLARK LAVENDER NITRILE POWER-FREE EXAM GLOVES	Kimberly-Clark Corp.	2008-07-09	68	0
K081027	KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STER	Kimberly-Clark Corp.	2008-06-30	81	1
K080821	MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE	Kimberly-Clark Corp.	2008-04-22	29	0
K080253	KIMBERLY-CLARK INTRODUCER KITS	Kimberly-Clark Corp.	2008-02-26	26	0
K052870	INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200	Kimberly-Clark Corp.	2006-09-29	353	0
K052824	KIMBERLY-CLARK PROCEDURE GOWN	Kimberly-Clark Corp.	2006-05-02	209	0
K051347	KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GL	Kimberly-Clark Corp.	2005-06-07	14	0
K043114	KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE	Kimberly-Clark Corp.	2004-12-10	30	0
K033021	KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UN	Kimberly-Clark Corp.	2003-11-12	47	2
K031750	SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE	Kimberly-Clark Corp.	2003-10-24	141	0
K012815	SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E A	Kimberly-Clark Corp.	2001-11-13	83	0
K011713	SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE	Kimberly-Clark Corp.	2001-07-05	31	0
K981393	MICROCOOL SURGICAL GOWN	Kimberly-Clark Corp.	1998-07-10	84	0
K974415	KIMBERLY-CLARK GAS PLASMA STERILIZATION INDICATOR STRIP	Kimberly-Clark Corp.	1998-07-10	228	0
K973827	KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZA	Kimberly-Clark Corp.	1998-02-11	127	0
K930149	KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+	Kimberly-Clark Corp.	1994-03-02	414	0
K925250	KOTEX(R) SECUREHOLD SUPER CURVE/CURVED MAXI PADS	Kimberly-Clark Corp.	1993-03-03	138	0
K920830	NEW FREEDOM ULTRA THIN PADS	Kimberly-Clark Corp.	1992-09-04	193	0
K896994	KOTEX SECURITY TAMPONS (SEVERAL TYPE)	Kimberly-Clark Corp.	1989-12-22	11	1
K894229	NEW FREEDOM ANYDAY PANTILINERS	Kimberly-Clark Corp.	1989-11-27	161	0
K890655	NEW FREEDOM THIN DEODORANT MAXI PADS	Kimberly-Clark Corp.	1989-05-01	82	0
K890654	NEW FREEDOM THIN SUPER & UNSCENTED, MAXI & SUPER	Kimberly-Clark Corp.	1989-04-25	76	0
K890013	KOTEX SUPER MAXI PADS	Kimberly-Clark Corp.	1989-04-25	112	0
K885194	KOTEX SECURITY TUBE TAMPONS	Kimberly-Clark Corp.	1989-03-01	75	0
K884305	KOTEX STICK TAMPONS, REGULAR AND SUPER	Kimberly-Clark Corp.	1988-12-20	68	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