New World Medical, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “New World Medical, Inc.” (first 1993, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 99 days. Since 2017 the median was 94 days, against 110 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 90 |
| 2017 | 1 | 83 |
| 2018 | 0 | — |
| 2019 | 1 | 127 |
| 2020 | 0 | — |
| 2021 | 1 | 129 |
| 2022 | 0 | — |
| 2023 | 2 | 33 |
| 2024 | 1 | 781 |
| 2025 | 1 | 94 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name New World Medical, Inc. took a median 94 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 110 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KYF | Implant, Eye Valve | 9 | 9 |
| MRH | Pump, Infusion, Ophthalmic | 2 | 2 |
| QUQ | Knife, Intraocular Pressure Lowering | 1 | 1 |
Review panels
- Ophthalmic (12)
Most recent New World Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243503 | VIA360 Surgical System | MRH | 2025-02-14 | 94 |
| K220891 | Kahook Dual Blade Glide (KDB Glide) | QUQ | 2024-05-17 | 781 |
| K231051 | Ahmed® Glaucoma Valve Model FP8 | KYF | 2023-05-12 | 29 |
| K230975 | Ahmed® Glaucoma Valve Model FP7 | KYF | 2023-05-12 | 37 |
| K211680 | Streamline Surgical System | MRH | 2021-10-08 | 129 |
| K182518 | AHMED ClearPath Glaucoma Drainage Device | KYF | 2019-01-18 | 127 |
| K171451 | Ahmed Glaucoma Valve Model FP8 | KYF | 2017-08-08 | 83 |
| K162060 | Ahmed Glaucoma Valve | KYF | 2016-10-24 | 90 |
| K060644 | AHMED GLAUCOMA VALVE, MODEL M4 | KYF | 2006-09-18 | 192 |
| K991072 | AHMED GLAUCOMA VALVE IMPLANT | KYF | 1999-07-13 | 104 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named New World Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named New World Medical, Inc. is the lead sponsor of 6 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT05696561: Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects With Open-Angle Glaucoma (Recruiting, started 2025-09-09)
- NCT05280366: STREAMLINE®SURGICAL SYSTEM Compared to iStent Inject W® in Patients With Open-Angle Glaucoma (Active not recruiting, started 2022-02-09)
- NCT05089474: A First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the STREAMLINE SURGICAL SYSTEM in Patients With Open-Angle Glaucoma (Completed, started 2021-03-08)
- NCT04700189: A FIH Trial of the STREAMLINE™ SURGICAL SYSTEM (Completed, started 2020-12-04)
- NCT05131087: A First-In-Human Clinical Trial to Evaluate the Safety, Effectiveness and Surgical Characteristics of CADENCE in Patients With Refractory Glaucoma (Completed, started 2020-10-08)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under New World Medical, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MRH)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MRH)
Frequently asked questions
How many FDA 510(k) clearances are listed under New World Medical, Inc.?
FDA lists 12 510(k) clearances under the applicant name “New World Medical, Inc.” (first 1993, latest 2025), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by New World Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name New World Medical, Inc. is 99 days. Since 2017: 94 days, versus 110 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under New World Medical, Inc.?
The most frequent FDA product codes under this applicant name are KYF (Implant, Eye Valve, 9); MRH (Pump, Infusion, Ophthalmic, 2); QUQ (Knife, Intraocular Pressure Lowering, 1).
Next steps
- See all 12 New World Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KYF, New World Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.