Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cowellmedi Co., Ltd. · Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
218 daysmedian FDA review time
617 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242287 | SFIT Abutment | Cowellmedi Co., Ltd. | 2025-09-16 | 410 | 0 |
| K241127 | INNO SLA Mini Plus® Implant System | Cowellmedi Co., Ltd. | 2024-12-27 | 248 | 0 |
| K231411 | INNO SLA Submerged Hybrid Ti-Base System | Cowellmedi Co., Ltd. | 2023-12-20 | 218 | 0 |
| K232546 | Meta G UCLA Abutment | Cowellmedi Co., Ltd. | 2023-11-21 | 90 | 0 |
| K231395 | INNO SLA Submerged Narrow Implant System | Cowellmedi Co., Ltd. | 2023-10-18 | 156 | 0 |
| K211554 | InnoGenic Non-resorbable Membrane | Cowellmedi Co., Ltd. | 2023-02-24 | 646 | 0 |
| K201323 | INNO SLA Submerged Implant System | Cowellmedi Co., Ltd. | 2022-01-25 | 617 | 0 |
| K132242 | INNO SLA SUBMERGED IMPLANT SYSTEM | Cowellmedi Co., Ltd. | 2013-12-06 | 141 | 0 |
| K100850 | COWELL IMPLANT SYSTEM | Cowellmedi Co., Ltd. | 2010-12-20 | 269 | 0 |
| K090054 | ATLAS IMPLANT SYSTEM - WIDE PLUS | Cowellmedi Co., Ltd. | 2009-07-29 | 202 | 0 |
| K090049 | ATLAS IMPLANT SYSTEM- MINI PLUS | Cowellmedi Co., Ltd. | 2009-04-20 | 103 | 0 |
| K071148 | ATLAS IMPLANT SYSTEM | Cowellmedi Co., Ltd. | 2008-02-06 | 288 | 0 |
| K050635 | ALLFIM IMPLANT SYSTEMS | Cowellmedi Co., Ltd. | 2005-07-28 | 119 | 0 |
| K041655 | BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS) | Cowellmedi Co., Ltd. | 2004-09-08 | 82 | 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