510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132380Substantially Equivalent

Prevantics Device Swab

Professional Disposables International, Inc., Orangeburg NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132380 is the FDA 510(k) clearance record for PREVANTICS DEVICE SWAB, cleared for Professional Disposables International, Inc. on under FDA product code LKB (Pad, Alcohol, Device Disinfectant). FDA records list one 510(k) clearance for Professional Disposables International, Inc. As of , FDA records show no recalls naming K132380.

Clearance record

Decision date
Received
(392 days to decision)
Product code
LKB Pad, Alcohol, Device Disinfectant
Device class
Unclassified
Review panel
Unknown
Applicant
Professional Disposables International, Inc. 2 Nice Pak Park, Orangeburg NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LKB

Trailing 12 months

FDA records hold no clearances under product code LKB in the trailing twelve months.

FDA records show no clearances under product code LKB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LKB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260