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Data / Medical devices / United States / Reckitt Benckiser LLC

Reckitt Benckiser LLC: FDA-registered device maker in Harrisburg, PA, United States, 22 510(k) clearances

Reckitt Benckiser LLC is registered with the FDA (registration 2531449) in Harrisburg, PA, United States. It lists 6 device types. The FDA files 22 510(k) clearances under its listings, the newest dated November 7, 2022. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Reckitt Benckiser LLC
FDA registration number
2531449
FEI number
3003979157
Address
360 Independence Avenue, Harrisburg, PA, United States, 17102
Owner or operator
Reckitt Benckiser LLC (9004884)
Roles
Repackager or relabeler
First device listed
May 23, 2007
Registered through
2026
Brand names listed
Durex 2 in 1 Massage Play Aloe Vera, Durex 2 in 1 Massage Play Guarana, Durex 2 in 1 Massage Play Ylang Ylang, Durex Adventure Pack, Durex Air Close Fit, Durex Cheeky Play Silicone Long Lasting Personal Lubricant, Durex Cheeky Play Silicone Long Lasting Pleasure Personal Lubricant, Durex Classic and more

Devices it lists

DeviceProduct codeClassRoleSource
CondomHIS2Repackager or relabeleraccessdata.fda.gov
Condom, SyntheticMOL2Repackager or relabeleraccessdata.fda.gov
Device, External Penile RigidityLKY2Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Repackager or relabeleraccessdata.fda.gov
Lubricant, PatientKMJ1Repackager or relabeleraccessdata.fda.gov
Lubricant, PersonalNUC2Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 7, 2022K220489Durex Patronus CloseFit, Durex Patronus RegularHISSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
May 11, 2022K211152Durex Condom with BenzocaineHISSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
March 1, 2022K213400Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play StrawberryNUCSubstantially EquivalentRb Health (Us)accessdata.fda.gov
July 9, 2021K211088Grosz Play FeelNUCSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
July 30, 2020K201186KY Grosz JellyNUCSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
April 20, 2020K193032KY Grosz LiquidNUCSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
April 14, 2020K192982KY Grosz UltraGelNUCSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
May 17, 2019K183505KY Banksy MoistureNUCSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
April 16, 2019K183302KY Banksy AloeNUCSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
January 12, 2018K173504K-Y SiliconeNUCSubstantially EquivalentReckitt Benckiser, LLCaccessdata.fda.gov
January 11, 2016K151884K-Y Marilyn Pleasure GelNUCSubstantially EquivalentReckitt Benckiser, LLCaccessdata.fda.gov
September 27, 2013K122219THEYFIT MALE CONDOMHISSubstantially EquivalentTheyfitaccessdata.fda.gov
December 7, 2011K113061LARGE/EXTRA LAGRE CONDOMHISSubstantially EquivalentKarex Industries Sdn. Bhd.accessdata.fda.gov
February 6, 2009K081886KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATEDHISSubstantially EquivalentKarex Industries Sdn. Bhd.accessdata.fda.gov
June 19, 2008K072169DUREX SYNTHETIC POLYISOPRENE MALE CONDOMMOLSubstantially EquivalentSsl Americas, Inc.accessdata.fda.gov
May 7, 2008K072236DUREX PLAY TINGLING AQUEOUS BASED LUBRICANTNUCSubstantially EquivalentSsl Americasaccessdata.fda.gov
March 10, 2008K063385DUREX PLAY MASSAGE GEL LUBRICANTNUCSubstantially EquivalentSsl Americas, Inc.accessdata.fda.gov
March 6, 2008K072421K-Y BRAND YOURS+MINENUCSubstantially EquivalentMcneil-Ppc, Inc.accessdata.fda.gov
March 23, 2007K070545K-Y BRAND WARMING LIQUIDNUCSubstantially EquivalentPersonal Products Co.accessdata.fda.gov
February 23, 2005K042563DUREX PLAY WARMER LUBRICANTKMJSubstantially EquivalentSsl Americas, Inc.accessdata.fda.gov
April 27, 2004K040185DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOMHISSubstantially EquivalentSsl Americasaccessdata.fda.gov
April 5, 2004K040164K-Y BRAND WARMING JELLY PERSONAL LUBRICANTNUCSubstantially EquivalentPersonal Products Company, Div. of Mcneil-Ppc, Inc.accessdata.fda.gov

Compare with other makers

Updated November 7, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.