SafeBeat Rx App— 510(k) K251218
Substantially EquivalentSafeBeat Rx, Inc.
FDA 510(k) clearance K251218 for SafeBeat Rx App, Substantially Equivalent on 2026-02-06. Applicant: SafeBeat Rx, Inc.. Device class: 2.
Summary
SafeBeat Rx's SafeBeat Rx App is filed under product code DQK (Computer, Diagnostic, Programmable). The record doesn't describe the app beyond its name and that code name.
Class II, 21 CFR 870.1425. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).
SafeBeat Rx filed from San Francisco, California. Review took 291 calendar days (April 21, 2025 to February 6, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- SafeBeat Rx, 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 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.