da Vinci 5

1. 5

   Regulator-cleared or mass marketThis robot

   A regulator has cleared it where approval applies: FDA clearance or approval for a medical robot, a permit to run with no one aboard for a self-driving vehicle, or an FAA approval for routine drone flights. Or: Widely sold: sales in the hundreds of thousands, or a product category you can buy in ordinary shops.

   Placed by: The FDA cleared da Vinci 5 for certain heart operations, such as mitral valve repair, done through small cuts between the ribs (26 Jan 2026); The FDA cleared da Vinci 5 through the 510(k) route (14 March 2024).

2. 4

   Paying customers

   Delivered to customers who pay for it, beyond a trial, or a paid service the public can use.

3. 3

   Pilot

   Working with a named customer in a real setting, as a trial.

4. 2

   Pre-orders

   Orders, reservations or deposits taken, with nothing delivered yet.

5. 1

   Demo only

   Shown in videos, staged events or a factory, with no units working for customers.

What we couldn't confirm. The FDA database lists further 510(k) clearances for the da Vinci 5 (model IS5000), including K251227 (Sept 2025), K251739 (Jan 2026) and K261824 (July 2026). We could not confirm what each one covers.