510(k) · Cleared
ClearedFemDx FalloView
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Femdx Medsystems, Inc. · MKO Falloposcope
Cleared on Mar 17, 2023 as substantially equivalent to K962587 (Conceptus, Inc., 1997) after a 255-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Mar 17, 2023
- Review
- 255 days
- Class
- Class II
- Product code
- MKO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962587 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK962587 Conceptus Fallopian Tube Catheteization with Microendoscopy SystemConceptus, Inc. · 1997
- This deviceK221965 FemDx FalloViewFemdx Medsystems, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962587 | Conceptus Fallopian Tube Catheteization with Microendoscopy System | Conceptus, Inc. | 1997 | — |
| 0 (this device) | K221965 | FemDx FalloView | Femdx Medsystems, Inc. | 2023 | — |
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 MKO? 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 |
|---|---|---|---|
| * | K962587 | Conceptus Fallopian Tube Catheteization with Microendoscopy SystemSummary page 4…Obstetrics/Gynecology Primary Predicate: Conceptus Fallopian Tube Catheterization with Microendoscopy (FTCM) System (K962587) Reference Devices: LiNA Medical ApS LiNA Opera Scope (K171113) Cook Incorporated Rö… | 1997 |
| † | K171113 | LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI… | 2018 |
| † | K171604 | Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set… | 2018 |
| † | K213171 | Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All MKO devicesMKO Falloposcope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MKO
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MKO
Too few MKO 510(k)s in any year since 2007 to give a median.
Recalls per year · MKO
No recall names MKO since 2007.
Adverse event reports per year · MKO
No MAUDE report names MKO since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 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 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The FemDx FalloViewTM is intended for visualization of the cervical canal, uterine cavity, and proximal fallopian tube(s) during diagnostic gynecological procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221965 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221965: FemDx FalloView.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221965
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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