Cleared Traditional

K132380 - PREVANTICS DEVICE SWAB (FDA 510(k) Clearance)

K132380 · Professional Disposables International, Inc. · General Hospital
Download Printable Device Report (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.

View all Professional Disposables International, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
263d slower than avg
Panel avg: 129d · This submission: 392d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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