510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260184Substantially Equivalent

Onclarity™ Self-Collection Kit

Becton Dickinson & Co, Sparks MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260184 is the FDA 510(k) clearance record for Onclarity™ Self-Collection Kit, a class II device, cleared for Becton, Dickinson and Company on under FDA product code SEP (Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay). FDA's definition for product code SEP reads: "A device for home collection and transport of vaginal specimens by lay users for HPV testing is a device intended for use by lay users in home settings or similar environments for the collection and transportation of vaginal specimens for...". FDA records list 345 510(k) clearances for Becton, Dickinson and Company, from to . As of , FDA records show no recalls naming K260184.

Clearance record

Decision date
Received
(71 days to decision)
Product code
SEP Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
Regulation
21 CFR 866.2920
Device class
Class II
Review panel
Microbiology
Applicant
Becton, Dickinson and Company 7loveton Cir., Sparks MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SEP

Trailing 12 months
1 clearance under product code SEP in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SEP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260