FDA 510(k)

Emanate Tray

K-Number: K251908 · 2026-07-29

Decision Date2026-07-29

Product CodeOLR

DecisionSubstantially Equivalent

Device Summary

Emanate Tray is the device name listed in this FDA 510(k) record. The listed applicant is Emanate Biomedical. It received FDA 510(k) clearance on 2026-07-29 under 510(k) number K251908. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Emanate Tray?

Emanate Tray is a medical device that received FDA 510(k) clearance on 2026-07-29. The listed applicant is Emanate Biomedical. The 510(k) number is K251908.

When did Emanate Tray receive FDA 510(k) clearance?

Emanate Tray received FDA 510(k) clearance on 2026-07-29, under 510(k) number K251908.

Who is the listed applicant for Emanate Tray?

The FDA 510(k) record lists Emanate Biomedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Emanate Tray?

The FDA product code for Emanate Tray is OLR.

Related Devices (Code: OLR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260126Curajel™ Oral GelUSpharma, Ltd.K253816MuCover (proposed name) Oral Wound DressingMoleculeX Co., Ltd.K253758Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn)K252425Silatrix Oral GelSa3, LLC K241283Elemental GranulateZinkh NV K230529HealiAid Dental Collagen Wound DressingMaxigen Biotech, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.