510(k) · Cleared
ClearedFemvue (TM) Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Femasys, Inc. · LKF Cannula, Manipulator/Injector, Uterine
Cleared on Jun 23, 2009 after a 193-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Jun 23, 2009
- Review
- 193 days
- Class
- Class II
- Product code
- LKF
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK083690 Femvue (TM) Catheter SystemFemasys, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK123258 The Advance Catheter for HSG and SisCatheter Research, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK160217 uVue HSG/SHG CatheterCook Incorporated · 2016
- Descendant · 2 generations on · 0 of its ownK181770 Intrauterine Access Balloon Catheter, Selective Salpingography…Cook Incorporated · 2019
- Descendant · 3 generations on · 0 of its ownK180291 Cook Silicone Balloon HSG CatheterCook Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK142545 SonoFlow Sonohysterography and Sonohysterosalpingography DeviceCrossbay Medical, Inc. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K123258The Advance Catheter for HSG and SisCatheter Research, Inc. · 2013 · cites it directly3descendants
- K160217uVue HSG/SHG CatheterCook Incorporated · 2016 · 2 generations on1descendant
- K181770Intrauterine Access Balloon Catheter, Selective Salpingography CatheterCook Incorporated · 2019 · 2 generations on0descendants
- K180291Cook Silicone Balloon HSG CatheterCook Incorporated · 2018 · 3 generations on0descendants
- K142545SonoFlow Sonohysterography and Sonohysterosalpingography DeviceCrossbay Medical, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083690 | Femvue (TM) Catheter System | Femasys, Inc. | 2009 | — |
| +1 | K123258 | The Advance Catheter for HSG and Sis | Catheter Research, Inc. | 2013 | — |
| +2 | K160217 | uVue HSG/SHG Catheter | Cook Incorporated | 2016 | — |
| +2 | K181770 | Intrauterine Access Balloon Catheter, Selective Salpingography Catheter | Cook Incorporated | 2019 | — |
| +3 | K180291 | Cook Silicone Balloon HSG Catheter | Cook Incorporated | 2018 | — |
| +1 | K142545 | SonoFlow Sonohysterography and Sonohysterosalpingography Device | Crossbay Medical, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 LKF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LKF device
- #1 K241693 FemChec Controlled Saline-Air Device (FCD-250)score 11.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | — | Ackrad H/S Catheter Set Named without a submission number | |
| * | — | AngioTech/MD Tech PBN Fallopian Tube Catheter System Named without a submission number | |
| * | — | Ackrad IUI Set for Intrauterine Insemination Named without a submission number | |
| * | — | Stargate Falloposcopy Catheter Named without a submission number | |
| * | — | Trifurcated Irrigation Tubing Named without a submission number |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K123258 (Catheter Research, Inc., 2013) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LKF devicesLKF Cannula, Manipulator/Injector, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LKF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LKF
136in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LKF
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKF
95in 2025
MAUDE reports naming product code LKF, 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 | 3 | 141 | 0 | 36 |
| 2008 | 0 | — | 2 | 59 |
| 2009 | 2 | — | 0 | 53 |
| 2010 | 6 | 178 | 0 | 46 |
| 2011 | 3 | 187 | 0 | 98 |
| 2012 | 0 | — | 2 | 104 |
| 2013 | 3 | 266 | 0 | 53 |
| 2014 | 3 | 169 | 0 | 45 |
| 2015 | 5 | 140 | 0 | 53 |
| 2016 | 1 | — | 0 | 62 |
| 2017 | 1 | — | 0 | 64 |
| 2018 | 4 | 267 | 0 | 23 |
| 2019 | 1 | — | 0 | 76 |
| 2020 | 0 | — | 0 | 119 |
| 2021 | 0 | — | 0 | 189 |
| 2022 | 4 | 79 | 3 | 100 |
| 2023 | 0 | — | 0 | 88 |
| 2024 | 3 | 136 | 0 | 125 |
| 2025 | 2 | — | 0 | 95 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The FemVue TM Catheter System is intended for the delivery of contrast media during hysterosalpingogram (HSG) and saline infusion hysterosonography (SIS) for the evaluation of the fallopian tube(s) selectively and/or the uterus. The following are some clinical indications: suspected polyps, fibroids, adhesions, or endometrial thickening, and/or the selective evaluation of fallopian tube patency.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083690 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083690: Femvue (TM) Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083690
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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