Cleared Traditional

Vitaform Procedural Mask - Blue (Vitaform Blue) (K251902) - FDA 510(k) Clearance

Also marketed or referenced as:
Vitaform Procedural Mask with Shield (Vitaform-FS)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251902 · Vitacore Industries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
89d
Days
Class 2
Risk

K251902 is an FDA 510(k) clearance for the Vitaform Procedural Mask - Blue (Vitaform Blue). Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Vitacore Industries, Inc. (Port Coquitlam, CA). The FDA issued a Cleared decision on September 17, 2025 after a review of 89 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vitacore Industries, Inc. devices

Submission Details

510(k) Number K251902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2025
Decision Date September 17, 2025
Days to Decision 89 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 129d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

Device Classification

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FXX Mask, Surgical

All 405
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K251902.
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