Emanate Tray— 510(k) K251908
Substantially EquivalentEmanate Biomedical
FDA 510(k) clearance K251908 for Emanate Tray, Substantially Equivalent on 2026-07-29. Applicant: Emanate Biomedical. Device class: Unclassified.
Summary
Emanate Biomedical's Emanate Tray is filed under OLR, oral wound dressings. The name says only "tray", and the record doesn't describe what the product contains.
Class U, with no regulation number. The classification panel is listed as Unknown, and the Dental review panel handled it as a Traditional 510(k).
Emanate Biomedical filed from New York, New York. Review took 404 calendar days (June 20, 2025 to July 29, 2026).
Clearance details
- Applicant
- Emanate Biomedical
- Product code
- Product code OLR
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Recent devices under product code OLR
view allAdverse events under product code OLR
product code OLR- Death
- 3
- Total
- 3
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.