Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Innobiosurg Co., Ltd. — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
168 daysmedian FDA review time
338 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220517 | IBS System | Innobiosurg Co., Ltd. | 2022-12-20 | 300 | 0 |
| K220079 | Magicore Narrow System | Innobiosurg Co., Ltd. | 2022-12-14 | 338 | 0 |
| K212517 | Magicore System | Innobiosurg Co., Ltd. | 2021-10-15 | 66 | 0 |
| K203344 | Premilled Titanium Block System | Innobiosurg Co., Ltd. | 2021-08-25 | 285 | 0 |
| K202418 | Magic UCLA Abutment System | Innobiosurg Co., Ltd. | 2020-12-03 | 101 | 0 |
| K202479 | IBS Implant System | Innobiosurg Co., Ltd. | 2020-09-23 | 26 | 0 |
| K201981 | Magicore System | Innobiosurg Co., Ltd. | 2020-08-27 | 42 | 0 |
| K201621 | Magicore II System | Innobiosurg Co., Ltd. | 2020-07-15 | 30 | 0 |
| K200753 | IBS Implant System II | Innobiosurg Co., Ltd. | 2020-06-09 | 78 | 0 |
| K192197 | Magicore II System | Innobiosurg Co., Ltd. | 2020-04-28 | 259 | 0 |
| K173120 | CCM Abutment System | Innobiosurg Co., Ltd. | 2018-03-16 | 168 | 0 |
| K162099 | IBS Implant System II | Innobiosurg Co., Ltd. | 2017-02-15 | 201 | 0 |
| K153350 | IBS Implant System | Innobiosurg Co., Ltd. | 2016-05-09 | 171 | 0 |
| K152520 | Magicore System | Innobiosurg Co., Ltd. | 2016-01-25 | 144 | 0 |
| K140806 | IBS IMPLANT SYSTEM | Innobiosurg Co., Ltd. | 2015-03-23 | 356 | 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