Cleared Traditional

K132380 - PREVANTICS DEVICE SWAB

K132380 · Professional Disposables International, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
392d
Days
-
Risk

K132380 is an FDA 510(k) clearance for the PREVANTICS DEVICE SWAB. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by Professional Disposables International, Inc. (Orangeburg, US). The FDA issued a Cleared decision on August 27, 2014 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel. 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K132380

510(k) Number K132380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2013
Decision Date August 27, 2014
Days to Decision 392 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
263d slower than avg
Panel avg: 129d · This submission: 392d
Pathway characteristics
Predicate-based equivalence.

LKB Device Classification - Class 0,

Product Code LKB Pad, Alcohol, Device Disinfectant
Device Class -

Regulatory Peers - LKB Pad, Alcohol, Device Disinfectant

All 18
Devices cleared under the same product code (LKB) and FDA review panel - the closest regulatory comparables to K132380.
BD ALCOHOL SWAB
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STERI-SWAB
K912731 · Westlock Investments (Usa), Inc. · Oct 1991
HEXIDIS ALCOHOL SWAB
K910735 · Specialites Septodont · Apr 1991
BOWEN ELECTRODE SKIN PREPATORY CLEANSER
K896898 · Bowen & Company, Inc. · Apr 1990
K132380 · PREVANTICS DEVICE SWAB
Download PDF FDA Summary Professional Disposab…