Data / Medical devices / United States / K. C. Pharmaceuticals, Inc.
K. C. Pharmaceuticals, Inc.: FDA-registered device maker in Pomona, CA, United States, 5 510(k) clearances
K. C. Pharmaceuticals, Inc. is registered with the FDA (registration 2026940) in Pomona, CA, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 2, 2020. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2026940
- Address
- 3220 Producer Way, Pomona, CA, United States, 91768
- Owner or operator
- K. C. PHARMACEUTICALS, INC. (9000438)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- December 31, 2018
- Registered through
- 2026
- Brand names listed
- BL-101-BEK1 Saline Solution 12 oz. Bottle, BL-3100-ACR03 Multipurpose Solution 12 oz. Bottle, BL-3100-ACR03 Multipurpose Solution 4 oz. Bottle, BL-3100-BPZ02 Multipurpose Solution 12 oz. Bottle, BL-3100-BPZ02 Multipurpose Solution 4 oz. Bottle, SMHP Lens Cleaning and Disinfecting Solution, 12oz
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Soft Lens Products | LPN | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Accessories, Solution, Ultrasonic Cleaners For Lenses | LYL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Products, Contact Lens Care, Rigid Gas Permeable | MRC | 2 | Complaint file establishment, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| March 2, 2020 | K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution | LPN | Substantially Equivalent | Menicon Co, Ltd. | accessdata.fda.gov |
| April 11, 2017 | K170483 | Bausch + Lomb Sensitive Eyes Plus Saline Solution | LPN | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| November 18, 2009 | K083757 | BPZ02 MULTIPURPOSE SOLUTION | LYL | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| May 31, 2002 | K020802 | RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION | LYL | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| December 20, 2001 | K010559 | SAUFLON MULTI LENS CARE SYSTEM | LPN | Substantially Equivalent | Sauflon Pharmaceuticals, Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 3, 2010 | 54656 | Not yet classified | Terminated | Publix Sterile Preserved Saline Solution 12oz, Product SKU#041415-003767. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection | The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile. | accessdata.fda.gov |
| October 4, 2004 | 30216 | Not yet classified | Terminated | Sterile Multi-Purpose Solution, NO RUB, for soft hydrophylic contact lenses. 12 fl oz. bottles. Sold under the following brand names: Family Dollar HomeBest HEB Meijer Food Lion health PRIDE Stop and Shop Super G sunmark | Routine testing indicates product does not meet the expiration date in all cases. | accessdata.fda.gov |
Compare with other makers
- All makers of Products, Contact Lens Care, Rigid Gas Permeable
- All makers of Accessories, Soft Lens Products
Updated March 2, 2020. 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.