Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Genoss Co., Ltd. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
261 daysmedian FDA review time
353 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242386 | Bluemoon | Genoss Co., Ltd. | 2025-05-05 | 266 | 0 |
| K222688 | The Trust | Genoss Co., Ltd. | 2024-08-09 | 703 | 0 |
| K233885 | rainbow Paste Stain SE | Genoss Co., Ltd. | 2024-06-21 | 196 | 0 |
| K232174 | rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono | Genoss Co., Ltd. | 2024-02-23 | 217 | 0 |
| K231480 | Bright MTA Sealer Plus | Genoss Co., Ltd. | 2023-07-28 | 67 | 0 |
| K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress- | Genoss Co., Ltd. | 2022-12-15 | 353 | 0 |
| K200155 | Bright High Flow | Genoss Co., Ltd. | 2020-11-30 | 313 | 0 |
| K200153 | Bright Bond Universal | Genoss Co., Ltd. | 2020-10-28 | 280 | 0 |
| K200156 | Bright Low Flow | Genoss Co., Ltd. | 2020-10-27 | 279 | 0 |
| K170596 | TN-Brush | Genoss Co., Ltd. | 2017-09-11 | 195 | 0 |
| K160079 | rainbow Shine | Genoss Co., Ltd. | 2016-11-10 | 301 | 0 |
| K153676 | OSTEON III | Genoss Co., Ltd. | 2016-09-14 | 268 | 0 |
| K160144 | rainbow LS Block | Genoss Co., Ltd. | 2016-07-21 | 182 | 0 |
| K112716 | OSTEON II | Genoss Co., Ltd. | 2012-01-17 | 120 | 0 |
| K102307 | GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODE | Genoss Co., Ltd. | 2011-05-04 | 261 | 0 |
| K102015 | OSTEON, OSTEON SINUS, OSTEON LIFTING | Genoss Co., Ltd. | 2010-11-19 | 126 | 0 |
| K092513 | RAINBOW BLOCK | Genoss Co., Ltd. | 2009-10-09 | 53 | 0 |
| K062834 | OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, | Genoss Co., Ltd. | 2007-04-24 | 215 | 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