# MacroLux Medical Technology Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 7 (2024–2026): 7 510(k) clearances
- Product codes: FGB (2), EOQ (2), FAJ (1), FED (1), HIH (1)
- 510(k) review time since 2016: median 130 days, against 140 for FDA's reviews in the same codes and years (4 of 7 faster)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Zhuhai Pusen Medical Technology Co., Ltd.: 3 (https://510kreport.com/company/zhuhai-pusen-medical-technology)
- Ambu A/S: 2 (https://510kreport.com/company/ambu-a-s)
- Guangzhou Red Pine Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-red-pine-medical-instrument)

## Firms that cite its devices most
- Zhejiang Geyi Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/zhejiang-geyi-medical-instrument)

## Its most-cited devices
- K240978: SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) (2024), cited by 1

## Recent decisions
- K260516: BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) (Jul 20, 2026)
- K260420: LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) (Apr 8, 2026)
- 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) (Jun 2, 2025)
- K240978: SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) (Aug 16, 2024)
- 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) (Jun 10, 2024)
- K233779: LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13) (Apr 5, 2024)
- 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) (Jan 11, 2024)

Source page: https://510kreport.com/company/macrolux-medical-technology