Data / Medical devices / United States / Kenvue Brands LLC
Kenvue Brands LLC: FDA-registered device maker in Summit, NJ, United States, 3 510(k) clearances
Kenvue Brands LLC is registered with the FDA (registration 2214133) in Summit, NJ, United States. It lists 11 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 29, 2015. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2214133
- Address
- 1 Kenvue Way, Summit, NJ, United States, 07901
- Owner or operator
- Kenvue Brands LLC (2214133)
- Roles
- Specification developer
- First device listed
- July 8, 2015
- Registered through
- 2027
- Brand names listed
- Aveeno, BAND-AID, Band-Aid, Benadryl, Bengay, Johnson & Johnson Red Cross, Listerine, Neutrogena and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Specification developer | accessdata.fda.gov |
| Cream, Nasal, Topical, Mechanical Allergen Particle Barrier | NUP | 2 | Specification developer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Specification developer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Specification developer | accessdata.fda.gov |
| First Aid Kit With Drug | LRR | N | Specification developer | accessdata.fda.gov |
| First Aid Kit Without Drug | OHO | 1 | Specification developer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Specification developer | accessdata.fda.gov |
| Otoscope | ERA | 1 | Specification developer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Specification developer | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | Specification developer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 29, 2015 | K143155 | LISTERINE Sensitivity Defense Mouthrinse | LBH | Substantially Equivalent | Johnson & Johnson Healthcare Products, Division of Mcneil-Pp | accessdata.fda.gov |
| December 31, 2013 | K132520 | NASAL EASE ALLERGY BLOCKER | NUP | Substantially Equivalent | Hi-Tech Pharmacal, Inc. | accessdata.fda.gov |
| November 22, 1995 | K954007 | PARALLEL | KGX | Substantially Equivalent | Johnson & Johnson Consumer Products, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 18, 2017 | 79454 | Class II | Terminated | COACH Self-Adhering Sports Wrap (size: 2in) | Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in the U.S. of select COACH Self-Adhering Sports Wraps, BAND-AID Brand First Aid Products SECURE-FLEX Wraps and BAND-AID Brand First Aid Products HURT-FREE Wraps products. The current labeling claim states not made with natural rubber latex which needs to be update | accessdata.fda.gov |
| January 25, 2013 | 64322 | Class II | Terminated | KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc. | This product is not cleared for marketing in the US. | accessdata.fda.gov |
| July 2, 2012 | 62948 | Class II | Terminated | KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant | Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA concerns that the product should have been cleared under a separate medical device application. This voluntary recall is not being conducted on the basis of any consumer safety or product performance issues related to K-Y LIQUIBEADS. JJHP received a Warning Lett | accessdata.fda.gov |
Compare with other makers
- All makers of Varnish, Cavity
- All makers of First Aid Kit Without Drug
- All makers of Dressing, Wound, Occlusive
- All makers of Gauze / Sponge,Nonresorbable For External Use
- All makers of Pack, Hot Or Cold, Disposable
- All makers of Bandage, Elastic
Updated March 27, 2018. 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.