FDA Tracker
Every ablation 510(k), the day FDA posts it.
Live from openFDA. Refreshed daily. Free, no account, no rate limit. Drop any clearance into Compass as a predicate candidate when you have a tenant.
510(k)
Sponsor
Class
Cleared
K253771
Vison Medical Equipment
II
2026-04-29
K252632
Surgnova Healthcare
II
2026-04-22
K251802
Crossfire Medical
II
2026-04-15
K243981
Boston Scientific
II
2026-04-08
K244012
Abbott
II
2026-04-01
cached fallback · openFDA unavailable
Want this dataset, AI-summarized?
Compass turns these into substantial-equivalence tables.
Pick three predicates from this list, paste their K-numbers into Compass, and get a draft SE comparison against your device in under a minute. The same RIG that powers the agent above.
Try the sandbox