ZEUS Platform (FG0501US)— 510(k) K252859
Substantially EquivalentiRhythm Technologies, Inc.
FDA 510(k) clearance K252859 for ZEUS Platform (FG0501US), Substantially Equivalent on 2026-05-29. Applicant: iRhythm Technologies, Inc.. Device class: 2.
Summary
iRhythm Technologies filed the ZEUS Platform (FG0501US) under DQK, programmable diagnostic computers. The record doesn't describe the platform beyond its name and that code name.
Class II, 21 CFR 870.1425. Cardiovascular is both the classification panel and the review panel, and it was a Traditional 510(k).
iRhythm is in San Francisco, California. Review took 262 calendar days, from September 9, 2025 to May 29, 2026.
Clearance details
- Applicant
- iRhythm Technologies, Inc.
- Product code
- Product code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Francisco, CA, US
Recent devices under product code DQK
view allMore clearances from iRhythm Technologies, Inc.
view allAdverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.