510(k) Report

FDA product code · Obstetrics and gynecology

Kit, Conception-Assist, Home Use

OBBClass II21 CFR 884.5250510(k) required4 decisions since 20070 recalls

4 FDA decisions since 2007. No recall names this code. The most-cited predicate is K063227, named by 2 later devices.

The kit is intended for assisted insemination in situations in which low sperm count , sperm immobility, or hostile vaginal environment have been diagnosed. The kit is used for semen collection and placement into the bowl of a cervical cap as an aid to conception. It is to be used at home following physician instruction. The Cap should not be left in place for more than 6 hours. The kit consists of: conception…

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, obstetrics and gynecology panel

Twenty years of OBB 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 · OBB

1in 2014

2007: 12008: 12012: 12014: 1
2007high 1 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OBB

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

Recalls per year · OBB

No recall names OBB since 2007.

Adverse event reports per year · OBB

2in 2023

2023: 2
2007high 2 (2023) · low 0 (2007)2025

MAUDE reports naming product code OBB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20081—00
20090—00
20100—00
20110—00
20121—00
20130—00
20141—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—02
20240—00
20250—00
20260—0—
FIG. 1 — OBB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OBB? 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 OBB devices cite most?

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

  • K063227Conceivex Conception KitConceivex, Inc. · 20072cite it
  • K112200Focus Touch Conception SystemIntimate Bridge 2 Conception, Inc. · 20121cites it

Which OBB devices have the deepest lineage?

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

  • K140186The Stork OtcRinovum Women'S Health, Inc. · 20143generations
  • K112200Focus Touch Conception SystemIntimate Bridge 2 Conception, Inc. · 20122generations
  • K080752Conceivex Latex-Free Semen CollectorConceivex, Inc. · 20082generations
  • K063227Conceivex Conception KitConceivex, Inc. · 20071generation

What has FDA decided in OBB lately?

  • K140186The Stork OtcRinovum Women'S Health, Inc. · 2014
  • K112200Focus Touch Conception SystemIntimate Bridge 2 Conception, Inc. · 2012
  • K080752Conceivex Latex-Free Semen CollectorConceivex, Inc. · 2008
  • K063227Conceivex Conception KitConceivex, Inc. · 2007

All 4 OBB decisions →

Related product codes

Other codes under 21 CFR 884.5250.

HDR Cap, CervicalMFD Cannula, Intrauterine Insemination