Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neobiotech Co., Ltd. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
149 daysmedian FDA review time
262 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232528 | Protective Cap | Neobiotech Co., Ltd. | 2024-04-30 | 253 | 0 |
| K232049 | IS-III active Short Implant | Neobiotech Co., Ltd. | 2024-03-28 | 262 | 0 |
| K210903 | IS Multi Unit Abutment System | Neobiotech Co., Ltd. | 2021-07-23 | 119 | 0 |
| K190849 | IS-III active System_S-narrow Type | Neobiotech Co., Ltd. | 2019-08-14 | 135 | 0 |
| K181137 | IT-III active System | Neobiotech Co., Ltd. | 2018-11-16 | 200 | 0 |
| K181138 | IS-III active System | Neobiotech Co., Ltd. | 2018-10-03 | 156 | 0 |
| K181178 | S-mini active Fixture | Neobiotech Co., Ltd. | 2018-07-24 | 83 | 0 |
| K173938 | IS-III HActive Fixture | Neobiotech Co., Ltd. | 2018-05-24 | 149 | 0 |
| K160991 | Neo GBR System | Neobiotech Co., Ltd. | 2017-01-10 | 277 | 0 |
| K120503 | CMI IMPLANT IS II ACTIVE | Neobiotech Co., Ltd. | 2012-06-18 | 118 | 0 |
| K113554 | CMI IMPLANT IS SYSTEM | Neobiotech Co., Ltd. | 2012-04-05 | 126 | 0 |
| K112540 | S-MINI IMPLANT SYSTEM | Neobiotech Co., Ltd. | 2012-02-03 | 155 | 0 |
| K111761 | NEO TITANIUM MESH, CTI-MEM | Neobiotech Co., Ltd. | 2012-01-10 | 201 | 0 |
| K090377 | SINUS QUICK EB SYSTEM | Neobiotech Co., Ltd. | 2009-08-28 | 192 | 0 |
| K090825 | SQ IS SYSTEM | Neobiotech Co., Ltd. | 2009-07-16 | 112 | 0 |
| K090527 | SINUS QUICK IT SYSTEM | Neobiotech Co., Ltd. | 2009-07-14 | 138 | 0 |
| K042339 | NEOPLANT IMPLANT SYSTEM | Neobiotech Co., Ltd. | 2004-11-02 | 64 | 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