Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
New World Medical, Inc. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
368 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243503 | VIA360™ Surgical System | New World Medical, Inc. | 2025-02-14 | 94 | 0 |
| K220891 | Kahook Dual Blade Glide (KDB Glide) | New World Medical, Inc. | 2024-05-17 | 781 | 0 |
| K230975 | Ahmed® Glaucoma Valve Model FP7 | New World Medical, Inc. | 2023-05-12 | 37 | 0 |
| K231051 | Ahmed® Glaucoma Valve Model FP8 | New World Medical, Inc. | 2023-05-12 | 29 | 0 |
| K211680 | Streamline Surgical System | New World Medical, Inc. | 2021-10-08 | 129 | 0 |
| K182518 | AHMED ClearPath Glaucoma Drainage Device | New World Medical, Inc. | 2019-01-18 | 127 | 0 |
| K171451 | Ahmed Glaucoma Valve Model FP8 | New World Medical, Inc. | 2017-08-08 | 83 | 0 |
| K162060 | Ahmed Glaucoma Valve | New World Medical, Inc. | 2016-10-24 | 90 | 0 |
| K060644 | AHMED GLAUCOMA VALVE, MODEL M4 | New World Medical, Inc. | 2006-09-18 | 192 | 0 |
| K991072 | AHMED GLAUCOMA VALVE IMPLANT | New World Medical, Inc. | 1999-07-13 | 104 | 0 |
| K980657 | AHMED GLAUCOMA VALVE, MODEL S3 | New World Medical, Inc. | 1998-04-20 | 74 | 0 |
| K925636 | AHMED GLAUCOMA VALVE IMPLANT | New World Medical, Inc. | 1993-11-12 | 368 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda