FDA applicant
Shockwave Medical, Inc.
FDA records 14 decisions for Shockwave Medical, Inc. (Santa Clara, CA) from 2016 to 2026: 13 510(k) clearances and 1 original PMA approval. Most are in product codes PPN (Percutaneous Catheter, Ultrasound) and QMG (Shockwave Intravascular Lithotripsy System). Since 2016 its 510(k)s took a median of 58 days from receipt to decision, against 56 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 11 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Shockwave Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2018
Class I Class II/III not classified
Planning a device like Shockwave Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report