Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PLL — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
178 daysmedian FDA review time
338 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241591 | Blue Eye | The Standard Co., Ltd. | 2024-07-03 | 30 | 0 |
| K220434 | Blue Eye (TS-905) | The Standard Co., Ltd. | 2022-08-12 | 178 | 0 |
| K221385 | LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.0 | Ovesco Endoscopy AG | 2022-08-11 | 90 | 0 |
| K200071 | Blue Beacon Submucosal Injectable Solution | Micro-Tech (Nanjing) Co., Ltd. | 2020-11-03 | 295 | 0 |
| K202376 | EverLift Submucosal Lifting Agent | Gi Supply, Inc. | 2020-09-30 | 41 | 0 |
| K191923 | EverLift Submucosal Lifting Agent | Gi Supply | 2020-06-20 | 338 | 0 |
| K191254 | EndoClot | Endoclot Plus Co., Ltd. | 2020-01-30 | 265 | 0 |
| K180068 | ORISE Gel | Boston Scientific | 2018-09-28 | 262 | 1 |
| K150852 | SIC 8000 | Cosmo Technologies, Ltd. | 2015-09-03 | 156 | 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