Many clients, especially those from bench-to-bedside tech transfer companies, often ask about the required fundraising and timelines to achieve their first FDA 510(k) clearance. To address this, we developed a two-part model analyzing public data from 37 AI/ML-enabled medical device companies, showing a median raise of $16 million and 25.7 months to first clearance. Follow-on 510(k)s typically require an additional $11.6 million each. Our approach carefully counts disclosed funding and acknowledges unreported capital and earlier work phases. Innolitics, with deep FDA experience and integrated regulatory, quality, and engineering services, enables clients to raise less—around $5 million—and achieve clearance in roughly 12 months, offering a 510(k) timeline and clearance guarantee when acceptance criteria are met. This model guides realistic fundraising plans