Cleared Traditional

NuStat (K183190) - FDA 510(k) Clearance

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

K183190 · Beeken Biomedical, LLC · General & Plastic Surgery device
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Sep 2019
Decision
310d
Days
Class 2
Risk

K183190 is an FDA 510(k) clearance for the NuStat. Classified as Temporary, Internal Use Hemostatic (product code POD), Class II - Special Controls.

Submitted by Beeken Biomedical, LLC (Stoughton, US). The FDA issued a Cleared decision on September 25, 2019 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4454 - the FDA general and plastic surgery 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Beeken Biomedical, LLC devices

Submission Details

510(k) Number K183190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2018
Decision Date September 25, 2019
Days to Decision 310 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 115d · This submission: 310d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code POD Temporary, Internal Use Hemostatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4454
Definition Intended To Control Severely Bleeding Wounds
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 & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Alira Health
Mary McNamara

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.