Company · US
Kimberly-Clark Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2023. Name variants (Inc, Corp, punctuation) are merged.
122510(k) clearances (0 in 12 months)
35recalls (0 in 12 months)
26recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HEB | Tampon, Menstrual, Unscented | 21 |
| FYA | Gown, Surgical | 17 |
| HHD | Pad, Menstrual, Unscented | 13 |
| FRG | Wrap, Sterilization | 12 |
| KKX | Drape, Surgical, Antimicrobial | 11 |
| LZA | Polymer Patient Examination Glove | 11 |
| HHL | Pad, Menstrual, Scented, Scented-Deodorized | 7 |
| BTR | Tube, Tracheal (W/Wo Connector) | 6 |
| CAZ | Anesthesia Conduction Kit | 6 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 5 |
| FXX | Mask, Surgical | 4 |
| BSY | Catheters, Suction, Tracheobronchial | 3 |
| DWJ | System, Thermal Regulating | 3 |
| KME | Bedding, Disposable, Medical | 3 |
| EYQ | Garment, Protective, For Incontinence | 2 |
| FYF | Cap, Surgical | 2 |
| KGC | Tube, Gastro-Enterostomy | 2 |
| LYZ | Vinyl Patient Examination Glove | 2 |
| LZC | Medical Glove, Specialty | 2 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 28, 2023 | K231435 | KIMTECH Polaris Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Kimberly-Clark Corporation | LZA |
| Jul 21, 2023 | K231021 | KIMTECH Polaris Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simul Kimberly-Clark Corporation | LZA |
| Jan 6, 2023 | K223749 | U by Kotex® Click® Unscented Menstrual Tampons Kimberly-Clark Corporation | HEB |
| Nov 30, 2020 | K202416 | Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Ga Kimberly Clark Corporation | LZA |
| Apr 10, 2020 | K200072 | KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastr Kimberly-Clark Corporation | LZA |
| Oct 11, 2017 | K172118 | U by Kotex Click Unscented Menstrual Tampons Kimberly-Clark Corporation | HEB |
| Dec 2, 2014 | K143164 | ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set Kimberly-Clark Corporation | BSO |
| Nov 10, 2014 | K140963 | KIMGUARD SMART-FOLD STERILIZATION WRAP Kimberly-Clark Corp. | FRG |
| Aug 25, 2014 | K141294 | U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS Kimberly-Clark Corp. | HEB |
| Jun 9, 2014 | K140539 | AERO BLUE PERFORMANCE SURGICAL GOWN Kimberly-Clark Corporation | FYA |
| Dec 20, 2013 | K131879 | KC 300 SURGICAL MASK Kimberly-Clark Corp. | FXX |
| Nov 7, 2013 | K131841 | KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE Kimberly-Clark Corp. | LZA |
| Aug 20, 2013 | K131254 | KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE Kimberly-Clark Corp. | BTR |
| Jun 26, 2013 | K122653 | MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES Kimberly-Clark Corporation | KNT |
| Dec 19, 2012 | K120985 | KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING Kimberly-Clark Corp. | BTR |
| Jul 11, 2012 | K120650 | POISE PERSONAL LUBRICANT Kimberly-Clark Corporation | NUC |
| Jun 22, 2012 | K112805 | KIMGUARD ONE-STEP STERILIZATION WRAP Kimberly-Clark Corp. | FRG |
| May 11, 2012 | K113333 | KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS Kimberly-Clark Corporation | BTR |
| May 4, 2012 | K113340 | KIMBERLY-CLARK CHILD'S FACEMASK Kimberly-Clark | OXZ |
| Mar 9, 2012 | K113423 | KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE Kimberly-Clark Corp. | LZA |
| Jan 19, 2012 | K112300 | KIMGUARD SMART-FOLD* STERILIZATION WRAP Kimberly-Clark Corp. | FRG |
| Dec 15, 2011 | K112562 | BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER Kimberly-Clark | OYI |
| Nov 2, 2011 | K113036 | U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS Kimberly-Clark Corporation | HEB |
| Oct 20, 2011 | K111402 | KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL Kimberly-Clark | FXX |
| Oct 7, 2011 | K112635 | U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS Kimberly-Clark Corp. | HEB |
| Sep 23, 2011 | K103150 | KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK Kimberly-Clark | OXZ |
| Apr 29, 2011 | K110455 | KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS Kimberly-Clark Corp. | FXX |
| Dec 23, 2010 | K103406 | MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS Kimberly-Clark Corp. | FYA |
| Dec 10, 2010 | K103311 | U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS Kimberly Clark Corporation | HEB |
| Nov 9, 2010 | K102666 | KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM Kimberly-Clark Corp. | KKX |
| Sep 8, 2010 | K102032 | KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS Kimberly-Clark Corp. | LZA |
| Jul 21, 2010 | K101596 | KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- Kimberly-Clark | LZC |
| Mar 19, 2010 | K093115 | KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100 Kimberly-Clark Corp. | FYA |
| Dec 23, 2009 | K091749 | U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS Kimberly-Clark Corp. | HEB |
| Dec 8, 2009 | K093312 | KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM Kimberly-Clark Corp. | KGC |
| Nov 2, 2009 | K092167 | KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600 Kimberly-Clark Corp. | FRG |
| Sep 3, 2009 | K091685 | KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600 Kimberly-Clark Corp. | FRG |
| Aug 10, 2009 | K091357 | MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 Kimberly-Clark Corp. | FYA |
| May 1, 2009 | K082554 | KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600 Kimberly-Clark Corp. | FRG |
| Mar 27, 2009 | K082177 | KIMGUARD ONE-STEP STERILIZATION WRAP Kimberly-Clark Corp. | FRG |
| Mar 25, 2009 | K083234 | KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 Kimberly-Clark Corp. | KKX |
| Sep 3, 2008 | K080795 | ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN Kimberly-Clark Corp. | FYA |
| Jul 14, 2008 | K081089 | KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM Kimberly-Clark Corp. | LZC |
| Jul 9, 2008 | K081260 | KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES Kimberly-Clark Corp. | LZA |
| Jun 30, 2008 | K081027 | KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE) Kimberly-Clark Corp. | LZA |
| Apr 22, 2008 | K080821 | MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE Kimberly-Clark Corp. | BTR |
| Feb 26, 2008 | K080253 | KIMBERLY-CLARK INTRODUCER KITS Kimberly-Clark Corp. | KGC |
| Sep 29, 2006 | K052870 | INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 Kimberly-Clark Corp. | NZP |
| May 2, 2006 | K052824 | KIMBERLY-CLARK PROCEDURE GOWN Kimberly-Clark Corp. | FYA |
| Jun 7, 2005 | K051347 | KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GLOVE Kimberly-Clark Corp. | LZA |
Newest 50 of 122.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2018 | Kimberly-Clark Corporation U by Kotex Sleek, Regular Tampons, 3 Count Terminated |
HEB | K112635 |
| Dec 11, 2018 | Kimberly-Clark Corporation U by Kotex Sleek, Regular/Super Tampons, 34 Count Multipack Terminated |
HEB | K112635 |
| Dec 11, 2018 | Kimberly-Clark Corporation U by Kotex Sleek, Regular Tampons, 34 Count Terminated |
HEB | K112635 |
| Dec 11, 2018 | Kimberly-Clark Corporation U by Kotex Sleek, Regular Tampons, 18 Count Terminated |
HEB | K112635 |
| Jan 28, 2014 | Kimberly-Clark Corporation Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10
The product is used to create lesions in Terminated |
GXI | K972846 |
| Dec 16, 2013 | Kimberly-Clark Corporation Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198)
Product Usage:
The device is designed to provide regional anesthesia. The device may contain s Terminated |
CAZ | K941153 |
| Mar 26, 2013 | Kimberly-Clark Corporation KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square.
Intended to be used to enclose another medical device that is to be sterilized by a health care provider. Terminated |
FRG | K881471 |
| Nov 29, 2012 | Kimberly-Clark Corporation Kimberly-Clark Patient Warming System - Model 1000 Control Unit
The product is a thermal regulating system, indicated for monitoring and controlling patient temperature. Terminated |
DWJ | K033021 |
| Nov 7, 2012 | Kimberly-Clark Corporation MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile
The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer Terminated |
FYA | K103406 |
| Nov 7, 2012 | Kimberly-Clark Corporation ULTRA Fabric Reinforced surgical Gown X-Large Sterile
The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of micro Terminated |
KKX | K103406 K842115 |
| Sep 20, 2012 | Kimberly-Clark Corporation Kimberly-Clark MIC PEG Kit - Pull Type
The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement techniqu Terminated |
KNT | None listed |
| Sep 20, 2012 | Kimberly-Clark Corporation Kimberly-Clark MIC Safety PEG Kit - Pull Type
The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement t Terminated |
KNT | None listed |
| Sep 20, 2012 | Kimberly-Clark Corporation ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File.
The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patien Terminated |
KKX | None listed |
| Aug 9, 2012 | Kimberly-Clark Corporation Kimberly Clark Patient Warming System - Model 1000 Control Unit.
Kimberly Clark Patient Warming System - Model 1000 Control Unit and Energy Transfer Pads is a thermal regulating system, indicated fo Terminated |
DWJ | K033021 |
| Jul 16, 2012 | Kimberly-Clark Corporation MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made in Honduras.
The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to Terminated |
FYA | K091357 |
| Jul 16, 2012 | Kimberly-Clark Corporation MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras.
The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn Terminated |
FYA | K091357 |
| Feb 2, 2012 | Kimberly-Clark Corporation KIMBERLY CLARK MIC GASTRO-ENTERIC FEEDING TUBE, 22F.
Gastro-Enteric Feeding Tube. Terminated |
KNT | K852707 |
| Jan 11, 2012 | Kimberly-Clark Corporation Kotex Natural Balance Security tampons, regular absorbency, unscented. packaged in 18 count or 36 count retail containers. Consumer Services, Kimberly-Clark Corp. Dept. KNBTR-18, P.O. Box 2020, Neen Terminated |
HEB | K896994 |
| Jul 21, 2011 | Kimberly-Clark Corporation Kimberly-Clark, Three Quarter Drape, Non sterile/Disposable,
Surgical drape. Terminated |
KKX | None listed |
| Jan 18, 2011 | Kimberly-Clark Corporation Ultra Surgical Gown, X-Large with Polypropylene Fabric and Towel, Reference number 95121-35, Single use only, Sterile, Made in Honduras. Terminated |
FYA | None listed |
| Jan 18, 2011 | Kimberly-Clark Corporation Ultra Surgical Gown, Large with Polypropylene Fabric and Towel, Reference number 95111-35, Single use only, Sterile, Made in Honduras. Terminated |
FYA | None listed |
| May 26, 2009 | Kimberly-Clark Corporation Kimberly-Clark, Synthetic Powder Free Vinyl Exam Gloves, Small, Medium and Large, 100 gloves per box, Non-Sterile, For Medical Use, Catalogue Numbers: 55031, 55032, and 55033. Distributed by Kimberly Terminated |
LYZ | K992821 |
| Aug 8, 2007 | Kimberly-Clark Corporation Kimberly Clark Microcuff Endotracheal Tube, Pediatric Oral Curved, sizes 3.0mm, 3.5mm, 4.0mm and 4.5mm, Rx Only, Sterile, Manufacturer: Kimberly-Clark NV Belgicastraat 13, 1930 Zaventem, Belgium, Made Terminated |
BTR | K050803 |
| Aug 8, 2007 | Kimberly-Clark Corporation Kimberly-Clark Microcuff Endotracheal Tube, Pediatric Oral/Nasal Magill, sizes 3.0mm, 3.5mm, 4.0mm, and 4.5mm, Rx Only, Sterile, Manufacturer: Kimberly-Clark NV Belgicastraat 13, 1930 Zaventem, Belgiu Terminated |
BTR | K050803 |
| Jul 28, 2006 | Kimberly-Clark Corporation Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for adults. Terminated |
MKJ | K935371 |
| Jul 28, 2006 | Kimberly-Clark Corporation Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode products for pediatrics. Terminated |
MKJ | K895729 |
| May 16, 2006 | Kimberly-Clark Corporation Kimberly Clark * Universal Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global States, In Terminated |
CAZ | K904440 |
| May 16, 2006 | Kimberly-Clark Corporation Kimberly Clark * Selective Nerve Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global Stat Terminated |
CAZ | K904440 |
| May 16, 2006 | Kimberly-Clark Corporation Kimberly Clark * Nerve Root Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global States, I Terminated |
CAZ | K904440 |
| May 16, 2006 | Kimberly-Clark Corporation Kimberly Clark * Nerve Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global States, Inc., Terminated |
CAZ | K904440 |
| May 16, 2006 | Kimberly-Clark Corporation Kimberly Clark * Facet Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global States, Inc., Terminated |
CAZ | K904440 |
| May 16, 2006 | Kimberly-Clark Corporation Kimberly Clark * 20' Minibore Extension Line * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global Sta Terminated |
FPK | K935642 |
| Jan 11, 2006 | Kimberly-Clark Corporation Kimberly-Clark/Ballard TRACH CARE Wet Pack * Y Adapter * Closed Suction System for Neonates * Rx Only * 8 Fr (2.66 mm) * 30.5 cm (12 in) * Single Use * Manufactured by Ballard Medical Products, Draper Terminated |
BSY | None listed |
| Jan 11, 2006 | Kimberly-Clark Corporation Kimberly-Clark/Ballard TRACH CARE* - 72 Wet Pak* for Adults * Closed Suction System with Saline Vials * Diameter 14 Fr (4.6 mm), Length 30.5 cm (12 in) * Rx Only * Single Use * Manufactured by Ballar Terminated |
BSY | None listed |
| Jan 11, 2006 | Kimberly-Clark Corporation Kimberly-Clark/Ballard TRACH CARE* - 72 Closed Suction products for Adults, Rx Only * Sterile * Diameter 14 Fr (4.6 mm), 54 cm (21.3 in) * Single Use * Made in Mexico, Manufactured by Ballard Medical Terminated |
BSY | None listed |