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FDA 510(k)

Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)

K-Number: K251902 · 2025-09-17

ApplicantVitacore Industries, Inc.
Decision Date2025-09-17
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) is a medical device manufactured by Vitacore Industries, Inc.. It received FDA 510(k) clearance on 2025-09-17 under approval number K251902. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)?

Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) is a medical device that received FDA 510(k) clearance on 2025-09-17. It is manufactured by Vitacore Industries, Inc.. The 510(k) number is K251902.

When was Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) approved by the FDA?

Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) received FDA 510(k) clearance on 2025-09-17, under approval number K251902.

What company makes Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)?

Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) is manufactured by Vitacore Industries, Inc..

What is the FDA product code for Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)?

The FDA product code for Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) is FXX.

Related Devices (Code: FXX)

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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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