Data / Medical devices / United States / Rhythm Ai Inc
Rhythm Ai Inc: FDA-registered device maker in La Jolla, CA, United States, 2 510(k) clearances
Rhythm Ai Inc is registered with the FDA (registration 3026523691) in La Jolla, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated July 26, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026523691
- Address
- 4225 Executive Square Suite 600, La Jolla, CA, United States, 92037
- Owner or operator
- Rhythm AI Inc (10087445)
- Roles
- Manufacturer
- First device listed
- February 28, 2023
- Registered through
- 2026
- Brand names listed
- STAR Apollo Mapping System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 26, 2024 | K240509 | STAR Apollo Mapping System | DQK | Substantially Equivalent | Rhythm AI, Ltd. | accessdata.fda.gov |
| December 1, 2022 | K220786 | STAR Apollo Mapping System | DQK | Substantially Equivalent | Rhythm Al, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 26, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.