DeepRhythmAI
FDA 510(k) clearance K253141 · decided 2025-12-11
Clearance details
- K-number
- K253141
- Device name
- DeepRhythmAI
- Applicant
- Medicalgorithmics S.A.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-25
- Decision date
- 2025-12-11
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Warsaw, PL
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medicalgorithmics S.A.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.