510(k) Report

FDA product code · Microbiology

Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

SEPClass II21 CFR 866.2920510(k) required2 decisions since 20250 recalls

2 FDA decisions since 2025. No recall names this code. The most-cited predicate is DEN240045, named by 2 later devices.

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 testing using an approved HPV molecular assay with which the device has been validated.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, microbiology panel

Twenty years of SEP at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · SEP

1in 2025

2025: 12026 (partial year): 1
2007high 1 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · SEP

Too few SEP 510(k)s in any year since 2007 to give a median.

Recalls per year · SEP

No recall names SEP since 2007.

Adverse event reports per year · SEP

No MAUDE report names SEP since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20251—00
20261—0—
FIG. 1 — SEP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in SEP? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do SEP devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • DEN240045Teal WandTeal Health, Inc. · 20252cite it

Which SEP devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K260184Onclarity™ Self-Collection KitBecton, Dickinson and Company · 20261generation

What has FDA decided in SEP lately?

  • K260184Onclarity™ Self-Collection KitBecton, Dickinson and Company · 2026
  • DEN240045Teal WandTeal Health, Inc. · 2025

All 2 SEP decisions →

Related product codes

Other codes under 21 CFR 866.2920.

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