FDA product code OBB: Kit, Conception-Assist, Home Use
OBB is the FDA product code for kit, conception-assist, home use. It is a Class II device, regulated under 21 CFR 884.5250 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 4 510(k) submissions under OBB, from 3 different applicants. The average 510(k) review took 192 days (median 154).
Definition
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 (cervical) caps; 3 polyurethane condoms; 24 ovulation predictors; 3 pregnancy test kits; 3 "sperm friendly" moisturizer samples (Pre Lubricant); 1 conception journal; 1 instruction manual; 2 conception wheels (1 in English and 1 in French); 1 medical provider envelope.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Conception-Assist, Home Use |
| Device class | Class II |
| Regulation | 21 CFR 884.5250 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OBB clearance
Top OBB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Conceivex, Inc. | 2 | 2008-05-14 |
| Rinovum Women'S Health, Inc. | 1 | 2014-07-11 |
| Intimate Bridge 2 Conception, Inc. | 1 | 2012-09-06 |
Most recent OBB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140186 | Rinovum Women'S Health, Inc. | THE STORK OTC | 2014-07-11 | 168 |
| K112200 | Intimate Bridge 2 Conception, Inc. | FOCUS TOUCH CONCEPTION SYSTEM | 2012-09-06 | 402 |
| K080752 | Conceivex, Inc. | CONCEIVEX LATEX-FREE SEMEN COLLECTOR | 2008-05-14 | 58 |
| K063227 | Conceivex, Inc. | CONCEIVEX CONCEPTION KIT | 2007-03-14 | 141 |
Recalls for OBB devices
openFDA lists no recalls for product code OBB.
Frequently asked questions
What is FDA product code OBB?
OBB is the FDA product code for kit, conception-assist, home use. It is a Class II device, regulated under 21 CFR 884.5250 and reviewed by the Obstetrics and Gynecology panel.
What device class is OBB?
Class II, regulation 21 CFR 884.5250. Typical premarket route: 510(k).
How long does a 510(k) take for product code OBB?
Across 4 cleared submissions the average was 192 days from receipt to decision (median 154).
Which companies have the most OBB clearances?
Conceivex, Inc. (2); Rinovum Women'S Health, Inc. (1); Intimate Bridge 2 Conception, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OBB
- Run a recall and safety report across every OBB manufacturer
- Watch product code OBB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Obstetrics and Gynecology product codes · FDA product code lookup · 510(k) database search · 510(k) review times