DistaSense(TM) (v1)— 510(k) K254058
Substantially EquivalentLife Detection Technologies
FDA 510(k) clearance K254058 for DistaSense(TM) (v1), Substantially Equivalent on 2026-09-25. Applicant: Life Detection Technologies. Device class: 2.
Summary
DistaSense (v1) from Life Detection Technologies is filed under DRT, cardiac monitors, a code that includes cardiotachometers and rate alarms. The record doesn't describe how the device senses or what it reports beyond that category.
Class II, 21 CFR 870.2300. The Cardiovascular panel reviewed it as a Traditional 510(k).
Life Detection Technologies filed from Sunnyvale, California. Review took 282 days (December 17, 2025 to September 25, 2026). That count is calendar days, not FDA review days.
Clearance details
- Applicant
- Life Detection Technologies
- Product code
- Product code DRT
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code DRT
view allAdverse events under product code DRT
product code DRT- Death
- 4
- Total
- 4
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.