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FDA 510(k)

PreOp v3

K-Number: K252565 · 2026-02-13

ApplicantClouds of Care
Decision Date2026-02-13
Product CodeOLX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PreOp v3 is the device name listed in this FDA 510(k) record. The listed applicant is Clouds of Care. It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K252565. The device is classified under product code OLX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PreOp v3?

PreOp v3 is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is Clouds of Care. The 510(k) number is K252565.

When did PreOp v3 receive FDA 510(k) clearance?

PreOp v3 received FDA 510(k) clearance on 2026-02-13, under 510(k) number K252565.

Who is the listed applicant for PreOp v3?

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

What is the FDA product code for PreOp v3?

The FDA product code for PreOp v3 is OLX.

Related Devices (Code: OLX)

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.

K260563CN-Suite™FIND Surgical Sciences Inc. D/B/A FIND NeuroK250239NeuroMatchLVIS CorporationK241513SourcererBrain Electrophysiology Laboratory Company, LLCK233985TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)Megin OYK210199RICOH MEGRicoh Company, Ltd.K201910EZTrackNeurologic, LLC

Official Source

View on FDA Database →

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

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