510(k) · Cleared
ClearedFemvue Saline-Air Device
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 Apr 28, 2011 as substantially equivalent to K020954 (Ackrad Laboratories, 2002) after an 86-day review. Its family tree reaches back 2 generations to 1988. 5 later devices descend from it.
- Decided
- Apr 28, 2011
- Review
- 86 days
- Class
- Class II
- Product code
- LKF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K881680 (1988). 5 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK881680 Ackrad H/S Procedure TrayAckrad Laboratories · 1988
- 1 generation backK020954 H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere…Ackrad Laboratories · 2002
- This deviceK110288 Femvue Saline-Air DeviceFemasys, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK241693 FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK253403 FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK242002 FemVue MINI Saline-Air DeviceFemasys, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK142545 SonoFlow Sonohysterography and Sonohysterosalpingography DeviceCrossbay Medical, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK143415 Air Bubble Based Infuser (ABBI)CooperSurgical, Inc. · 2015
Most influential descendants
Showing 5 of 5 · See all- K241693FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc. · 2024 · cites it directly1descendant
- K253403FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc. · 2025 · 2 generations on0descendants
- K242002FemVue MINI Saline-Air DeviceFemasys, Inc. · 2024 · cites it directly0descendants
- K142545SonoFlow Sonohysterography and Sonohysterosalpingography DeviceCrossbay Medical, Inc. · 2015 · cites it directly0descendants
- K143415Air Bubble Based Infuser (ABBI)CooperSurgical, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K881680 | Ackrad H/S Procedure Tray | Ackrad Laboratories | 1988 | — |
| −1 | K020954 | H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere Procedure… | Ackrad Laboratories | 2002 | — |
| 0 (this device) | K110288 | Femvue Saline-Air Device | Femasys, Inc. | 2011 | — |
| +1 | K241693 | FemChec Controlled Saline-Air Device (FCD-250) | Femasys, Inc. | 2024 | — |
| +2 | K253403 | FemVue® Controlled Saline-Air Device (FSA-300) | Femasys, Inc. | 2025 | — |
| +1 | K242002 | FemVue MINI Saline-Air Device | Femasys, Inc. | 2024 | — |
| +1 | K142545 | SonoFlow Sonohysterography and Sonohysterosalpingography Device | Crossbay Medical, Inc. | 2015 | — |
| +1 | K143415 | Air Bubble Based Infuser (ABBI) | CooperSurgical, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K020954 | H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere Procedure Tray &…Summary page 1…valuation of the fallopian tubes with or without assessment of the uterine cavity. Predicate Device: Ackrad H/S Elliptosphere Procedure Tray K020954 Page l of 2 510(k) Summary far the FemVue T M Saline-Air De… | 2002 |
What descends from it? (5)
4 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?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 13.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K241693 (Femasys, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K020954.
How does its category compare?
All LKF devicesLKF Cannula, Manipulator/Injector, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 FemVueTM Saline-Air Device instills a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110288: Femvue Saline-Air Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110288
Report an extraction error
Are you the manufacturer?
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