Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MacroLux Medical Technology Co., Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
130 daysmedian FDA review time
209 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260516 | BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C | MacroLux Medical Technology Co., Ltd. | 2026-07-20 | 153 | 0 |
| K260420 | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B | MacroLux Medical Technology Co., Ltd. | 2026-04-08 | 58 | 0 |
| K250452 | CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0 | MacroLux Medical Technology Co., Ltd. | 2025-06-02 | 104 | 0 |
| K240978 | SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, H | MacroLux Medical Technology Co., Ltd. | 2024-08-16 | 128 | 0 |
| K240283 | BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C | MacroLux Medical Technology Co., Ltd. | 2024-06-10 | 130 | 0 |
| K233779 | LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38 | MacroLux Medical Technology Co., Ltd. | 2024-04-05 | 130 | 0 |
| K231774 | CoralView® Single-use Digital Flexible Ureteroscope (U10); C | MacroLux Medical Technology Co., Ltd. | 2024-01-11 | 209 | 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