MacroLux Medical Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “MacroLux Medical Technology Co., Ltd.” (first 2024, latest 2026), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 130 days. Since 2017 the median was 130 days, against 137 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2024 | 4 | 130 |
| 2025 | 1 | 104 |
| 2026 | 2 | 106 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name MacroLux Medical Technology Co., Ltd. took a median 130 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 137 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 2 | 2 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 2 | 2 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 1 | 1 |
| HIH | Hysteroscope (And Accessories) | 1 | 1 |
Review panels
Most recent MacroLux Medical Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260516 | BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) | FGB | 2026-07-20 | 153 |
| K260420 | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) | EOQ | 2026-04-08 | 58 |
| K250452 | CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B) | FED | 2025-06-02 | 104 |
| K240978 | SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) | HIH | 2024-08-16 | 128 |
| K240283 | BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S) | FAJ | 2024-06-10 | 130 |
| K233779 | LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13) | EOQ | 2024-04-05 | 130 |
| K231774 | CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR) | FGB | 2024-01-11 | 209 |
Recalls
openFDA lists no recalls under a recalling firm named MacroLux Medical Technology Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under MacroLux Medical Technology Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “MacroLux Medical Technology Co., Ltd.” (first 2024, latest 2026), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by MacroLux Medical Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name MacroLux Medical Technology Co., Ltd. is 130 days. Since 2017: 130 days, versus 137 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under MacroLux Medical Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are EOQ (Bronchoscope (Flexible Or Rigid), 2); FGB (Ureteroscope And Accessories, Flexible/Rigid, 2); FAJ (Cystoscope And Accessories, Flexible/Rigid, 1).
Next steps
- See all 7 MacroLux Medical Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EOQ, MacroLux Medical Technology Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.