Cleared Traditional

Spin Care Disposable Protective Mask Level 3 (K212109) - FDA 510(k) Clearance

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

K212109 · Spintech, LLC · General Hospital
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Nov 2021
Decision
131d
Days
Class 2
Risk

K212109 is an FDA 510(k) clearance for the Spin Care Disposable Protective Mask Level 3. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Spintech, LLC (Statesville, US). The FDA issued a Cleared decision on November 14, 2021 after a review of 131 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Spintech, LLC devices

Submission Details

510(k) Number K212109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2021
Decision Date November 14, 2021
Days to Decision 131 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 No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 129d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Rogers Consulting
W. Victoria Rogers

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FXX Mask, Surgical

All 404
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K212109.
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