510(k) · Cleared
ClearedFocus Touch Conception System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intimate Bridge 2 Conception, Inc. · OBB Kit, Conception-Assist, Home Use
Cleared on Sep 6, 2012 as substantially equivalent to K063227 (Conceivex, Inc., 2007) after a 402-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- Sep 6, 2012
- Review
- 402 days
- Class
- Class II
- Product code
- OBB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K902936 (1991). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK902936 Polyurethane CondomApex Medical Technologies, Inc. · 1991
- 1 generation backK063227 Conceivex Conception KitConceivex, Inc. · 2007
- This deviceK112200 Focus Touch Conception SystemIntimate Bridge 2 Conception, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK140186 The Stork OtcRinovum Women'S Health, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K140186The Stork OtcRinovum Women'S Health, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902936 | Polyurethane Condom | Apex Medical Technologies, Inc. | 1991 | — |
| −1 | K063227 | Conceivex Conception Kit | Conceivex, Inc. | 2007 | — |
| 0 (this device) | K112200 | Focus Touch Conception System | Intimate Bridge 2 Conception, Inc. | 2012 | — |
| +1 | K140186 | The Stork Otc | Rinovum Women'S Health, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OBB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063227 | Conceivex Conception KitSummary page 1…Prdcteie: Manufacturer Device Name 510(k) Number PreicteDeics: Conceivex, Inc Conception Kit K063227 Reason for Submission New Device 510(k) Number: KI112200 Description of Device The Focus TouchTM Conception S… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140186 | The Stork Otc | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 16.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K140186 (Rinovum Women'S Health, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K063227.
How does its category compare?
All OBB devicesOBB Kit, Conception-Assist, Home Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OBB
1in 2014
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
MAUDE reports naming product code OBB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Focus Touch Conception System is indicated for assisted insemination in instances where low sperm count, sperm immobility, or hostile vaginal environment has been diagnosed. The system (cervical cap in a condom-like silicone sheath) is used to collect semen into a cervical cap, and then deliver the cap to the outside of the cervix as an aid to conception. It is to be used at home following physician instruction. The Focus Touch Conception System should not be left in place for longer than 6 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112200: Focus Touch Conception System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112200
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026