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FDA 510(k)

Hypnos (369054-200)

K-Number: K250851 · 2025-12-14

ApplicantCadwell Industries, Inc.
Decision Date2025-12-14
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Hypnos (369054-200) is the device name listed in this FDA 510(k) record. The listed applicant is Cadwell Industries, Inc.. It received FDA 510(k) clearance on 2025-12-14 under 510(k) number K250851. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hypnos (369054-200)?

Hypnos (369054-200) is a medical device that received FDA 510(k) clearance on 2025-12-14. The listed applicant is Cadwell Industries, Inc.. The 510(k) number is K250851.

When did Hypnos (369054-200) receive FDA 510(k) clearance?

Hypnos (369054-200) received FDA 510(k) clearance on 2025-12-14, under 510(k) number K250851.

Who is the listed applicant for Hypnos (369054-200)?

The FDA 510(k) record lists Cadwell Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hypnos (369054-200)?

The FDA product code for Hypnos (369054-200) is OLZ.

Other records listing Cadwell Industries, Inc. as applicant

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Related Devices (Code: OLZ)

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.

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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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