510(k) Report

FDA applicant

New World Medical, Inc.

Rancho Cucamonga, CA12 decisions1993–20250 recalls

FDA records 12 decisions for New World Medical, Inc. (Rancho Cucamonga, CA) from 1993 to 2025: 12 510(k) clearances. Most are in product codes KYF (Implant, Eye Valve) and MRH (Pump, Infusion, Ophthalmic). Its devices cite 14 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided New World Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2016: 12017: 12019: 12021: 12023: 22024: 12025: 1
2007high 2 (2023) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — New World Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like New World Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • KYFImplant, Eye Valve9decisions
  • MRHPump, Infusion, Ophthalmic2decisions
  • QUQKnife, Intraocular Pressure Lowering1decision

Whose devices does it build on?

Its devices cite 14 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 6 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K925636Ahmed Glaucoma Valve ImplantNew World Medical, Inc. · 19933cite it
  • K162060Ahmed Glaucoma ValveNew World Medical, Inc. · 20162cite it
  • K980657Ahmed Glaucoma Valve, Model S3New World Medical, Inc. · 19982cite it
  • K171451Ahmed Glaucoma Valve Model FP8New World Medical, Inc. · 20171cites it

What has FDA decided for it lately?

  • K243503VIA360™ Surgical SystemNew World Medical, Inc. · 2025
  • K220891Kahook Dual Blade Glide (KDB Glide)New World Medical, Inc. · 2024
  • K230975Ahmed® Glaucoma Valve Model FP7New World Medical, Inc. · 2023
  • K231051Ahmed® Glaucoma Valve Model FP8New World Medical, Inc. · 2023
  • K211680Streamline Surgical SystemNew World Medical, Inc. · 2021
  • K182518AHMED ClearPath Glaucoma Drainage DeviceNew World Medical, Inc. · 2019
  • K171451Ahmed Glaucoma Valve Model FP8New World Medical, Inc. · 2017
  • K162060Ahmed Glaucoma ValveNew World Medical, Inc. · 2016

All 12 as New World Medical, Inc. →