[{"data":1,"prerenderedAt":23},["ShallowReactive",2],{"news-detail-882-en":3},{"id":4,"date":5,"date_gmt":6,"modified":7,"modified_gmt":8,"title":9,"excerpt":11,"content":12,"featured_image":15,"categories":16,"tags":18,"sort_order":19,"focus_keyphrase":20,"seo_title":21,"seo_description":22},882,"2026-04-30T10:17:12","2026-04-30T02:17:12","2026-08-13T14:51:47","2026-08-13T06:51:47",{"rendered":10},"Fertsy Successfully Obtains Its First FDA 510(k) Clearance","\u003Cp>Recently, Fertsy’s self-developed negative pressure oocyte retrieval pump (model: AD-VPUM-500) officially received U.S. Food and Drug Administration (FDA) 510(k) clearance, officially gaining market access in the United \u003C\u002Fp>\n",{"rendered":13,"protected":14},"\u003Cp class=\"wp-block-paragraph\">Recently, Fertsy’s self-developed negative-pressure oocyte retrieval pump (model: AD-VPUM-500) received U.S. Food and Drug Administration (FDA) 510(k) clearance, securing market access in the United States.\u003C\u002Fp>\n\n\n\n\u003Cp class=\"wp-block-paragraph\">This is Fertsy’s first FDA 510(k) clearance and the company’s first cleared active medical device. This milestone demonstrates that the product’s quality, safety, and compliance meet leading global standards, providing an “international passport” to the global market.\u003C\u002Fp>\n\n\n\n\u003Cfigure class=\"wp-block-image size-full is-resized is-style-rounded\">\u003Cimg loading=\"lazy\" decoding=\"async\" src=\"https:\u002F\u002Fshengshengyi.com\u002Fwp-content\u002Fuploads\u002F2026\u002F04\u002F%E5%BE%AE%E4%BF%A1%E5%9B%BE%E7%89%87_20260429162712_397_328-1.png\" alt=\"\" class=\"wp-image-781 fertsy-content-image fertsy-content-image--wide\" style=\"display:block;max-width:90%;width:90%;height:auto;aspect-ratio:696 \u002F 356;object-fit:contain;margin:24px auto;\" sizes=\"auto, (max-width: 696px) 100vw, 696px\">\u003C\u002Ffigure>\n\n\n\n\u003Ch2 class=\"wp-block-heading\">1. Core Technological Advantages: Ensuring Oocyte Safety\u003C\u002Fh2>\n\u003Cp class=\"wp-block-paragraph\">The negative-pressure oocyte retrieval pump is primarily used in assisted reproduction technology (ART) procedures to aspirate oocytes through low-flow, intermittent negative pressure. Addressing clinical requirements for stability and control, the device has been systematically optimized for negative pressure accuracy, response control, and user experience, providing fertility centers with safer and more reliable equipment support.\u003C\u002Fp>\n\n\n\n\u003Cdiv class=\"wp-block-media-text is-stacked-on-mobile\">\u003Cfigure class=\"wp-block-media-text__media\">\u003Cimg loading=\"lazy\" decoding=\"async\" src=\"https:\u002F\u002Fshengshengyi.com\u002Fwp-content\u002Fuploads\u002F2026\u002F04\u002Fpump-1024x539.png\" alt=\"\" class=\"wp-image-777 size-full fertsy-content-image fertsy-content-image--wide\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" style=\"display:block;max-width:90%;width:90%;height:auto;aspect-ratio:1024 \u002F 539;object-fit:contain;margin:24px auto;\">\u003C\u002Ffigure>\u003Cdiv class=\"wp-block-media-text__content\">\n\u003Cp class=\"wp-block-paragraph\">Intelligent algorithm controls negative pressure output with adaptive regulation of pressure changes, reducing fluctuation interference for a smoother and more controllable aspiration process. Low-noise operation design ensures the device runs quietly and smoothly, minimizing operational interference and enhancing clinical focus. Sustained stable negative pressure performance maintains consistent output across different operation stages, reducing uncertainty from manual adjustments.\u003C\u002Fp>\n\u003C\u002Fdiv>\u003C\u002Fdiv>\n\n\n\n\u003Ch2 class=\"wp-block-heading\">2. Human-Centered Design for More Efficient Operation\u003C\u002Fh2>\n\n\n\n\u003Cdiv class=\"wp-block-media-text is-stacked-on-mobile\">\u003Cfigure class=\"wp-block-media-text__media\">\u003Cimg loading=\"lazy\" decoding=\"async\" src=\"https:\u002F\u002Fshengshengyi.com\u002Fwp-content\u002Fuploads\u002F2026\u002F04\u002FVacuum_pump_03-1024x706.png\" alt=\"\" class=\"wp-image-778 size-full fertsy-content-image fertsy-content-image--wide\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" style=\"display:block;max-width:90%;width:90%;height:auto;aspect-ratio:1024 \u002F 706;object-fit:contain;margin:24px auto;\">\u003C\u002Ffigure>\u003Cdiv class=\"wp-block-media-text__content\">\n\u003Cp class=\"wp-block-paragraph\">Knob-based adjustment provides intuitive operation and rapid response, reducing the learning curve. Foot control mode supports hands-free operation, improving procedural continuity and efficiency. Adjustable prompt feedback allows volume customization, ensuring information delivery while minimizing environmental interference.\u003C\u002Fp>\n\u003C\u002Fdiv>\u003C\u002Fdiv>\n\n\n\n\u003Ch2 class=\"wp-block-heading\">3. Full Alignment with International Regulatory Standards\u003C\u002Fh2>\n\n\n\n\u003Cp class=\"wp-block-paragraph\">The U.S. Food and Drug Administration (FDA) is globally recognized as one of the most rigorous and authoritative medical regulatory agencies, with extensive influence worldwide. Its regulatory system is referenced or adopted by nearly 200 countries and regions.\u003C\u002Fp>\n\n\n\u003Cp class=\"wp-block-paragraph\">Obtaining FDA 510(k) clearance not only helps rapidly open the core North American market but also significantly enhances the efficiency and recognition of product registration in other international markets, providing crucial support for global business expansion. For medical devices, FDA registration means:\u003C\u002Fp>\n\n\n\n\u003Cul class=\"wp-block-list fertsy-check-list\">\u003Cli>Product safety and effectiveness are scientifically validated.\u003C\u002Fli>\u003Cli>The manufacturing system complies with QSR 820 quality system requirements.\u003C\u002Fli>\u003Cli>The entire process—from R&D and manufacturing to quality control—meets the world-class regulatory standards set by the U.S. Food and Drug Administration.\u003C\u002Fli>\u003C\u002Ful>\n\n\n\n\u003Ch2 class=\"wp-block-heading\">4. Continuous Innovation: Advancing into Broader Global Markets\u003C\u002Fh2>\n\n\n\n\u003Cp class=\"wp-block-paragraph\">Fertsy always adheres to the development philosophy of ‘Innovation, Quality, Compliance,’ focusing on providing safer, more efficient, and reliable medical device products and solutions for the global reproductive medicine field.\u003C\u002Fp>\n\n\n\n\u003Cp class=\"wp-block-paragraph\">In the future, the company will continue to be guided by international standards, continuously enhance its technical strength and product competitiveness, accelerate its global expansion, and serve more medical institutions and patients.\u003C\u002Fp>\n\n\n\n\u003Cblockquote class=\"wp-block-quote fertsy-article-callout\">\u003Cp>Certification is the starting point; quality is timeless.\u003C\u002Fp>\u003C\u002Fblockquote>\n\n\n\n\u003Cp class=\"wp-block-paragraph\">Fertsy will continue to take professionalism and quality as its cornerstones, advancing Chinese medical devices onto a broader world stage.\u003C\u002Fp>",false,"https:\u002F\u002Fshengshengyi.com\u002Fwp-content\u002Fuploads\u002F2026\u002F04\u002FChatGPT-Image-2026年4月29日-19_36_59.png",[17],3,[],0,"FDA 510(k) clearance","FDA 510(k) clearance | Fertsy","Recently, Fertsy’s self-developed negative pressure oocyte retrieval pump (model: AD-VPUM-500) officially received U.S. Food and Drug Administration (FDA)…",1786842061694]