FDA applicant
Rhythm AI, Ltd.
FDA records 3 decisions for Rhythm AI, Ltd. (London, GB) from 2024 to 2026: 3 510(k) clearances. All are in product code DQK (Computer, Diagnostic, Programmable). Since 2016 its 510(k)s took a median of 29 days from receipt to decision, against 100 for FDA’s reviews in the same codes and years. Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Rhythm AI, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Rhythm AI, Ltd.’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) ReportOther applicant names beginning “Rhythm”
FDA records each applicant name separately; these may or may not be the same firm.