Data / Medical devices / United States / New World Medical, Inc.
New World Medical, Inc.: FDA-registered device maker in Rancho Cucamonga, CA, United States, 6 510(k) clearances
New World Medical, Inc. is registered with the FDA (registration 1000125279) in Rancho Cucamonga, CA, United States. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 14, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1000125279
- Address
- 10763 Edison Court, Rancho Cucamonga, CA, United States, 91730
- Owner or operator
- New World Medical, Inc. (10027863)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 18, 2019
- Registered through
- 2026
- Brand names listed
- Ahmed Glaucoma Valve, Kahook Dual Blade Glide, Streamline Surgical System, VIA360 Surgical System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Ophthalmic | HMX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Implant, Eye Valve | KYF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Knife, Intraocular Pressure Lowering | QUQ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Pump, Infusion, Ophthalmic | MRH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Trabeculotome | HMZ | 1 | Complaint file establishment, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| February 14, 2025 | K243503 | VIA360 Surgical System | MRH | Substantially Equivalent | New World Medical, Inc. | accessdata.fda.gov |
| May 17, 2024 | K220891 | Kahook Dual Blade Glide (KDB Glide) | QUQ | Substantially Equivalent | New World Medical, Inc. | accessdata.fda.gov |
| May 12, 2023 | K231051 | Ahmed® Glaucoma Valve Model FP8 | KYF | Substantially Equivalent | New World Medical, Inc. | accessdata.fda.gov |
| May 12, 2023 | K230975 | Ahmed® Glaucoma Valve Model FP7 | KYF | Substantially Equivalent | New World Medical, Inc. | accessdata.fda.gov |
| October 8, 2021 | K211680 | Streamline Surgical System | MRH | Substantially Equivalent | New World Medical, Inc. | accessdata.fda.gov |
| January 18, 2019 | K182518 | AHMED ClearPath Glaucoma Drainage Device | KYF | Substantially Equivalent | New World Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Knife, Intraocular Pressure Lowering
- All makers of Implant, Eye Valve
- All makers of Trabeculotome
- All makers of Pump, Infusion, Ophthalmic
- All makers of Cannula, Ophthalmic
Updated February 14, 2025. 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.