510(k) · Cleared
ClearedFemchec Pressure Managemet 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 Oct 12, 2011 as substantially equivalent to K020954 (Ackrad Laboratories, 2002) and 2 other predicates after a 187-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Oct 12, 2011
- Review
- 187 days
- Class
- Class II
- Product code
- LKF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K000704 (2000). 7 ancestors in all, the oldest K792134 (1979). No later device cites it as a predicate yet.
- Root · 3 generations backK000704 DMC Saphenous Vein Distention System (SVDS)Dmc Medical, Ltd. · 2000
- 2 generations backK043515 GraftsaverVescare, Inc. · 2005
- 1 generation backK082725 Graftguard Pressure Controlling SyringeMaquet Cardiovascular, LLC · 2008 · Recalled
- This deviceK110993 Femchec Pressure Managemet DeviceFemasys, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000704 | DMC Saphenous Vein Distention System (SVDS) | Dmc Medical, Ltd. | 2000 | — |
| −2 | K043515 | Graftsaver | Vescare, Inc. | 2005 | — |
| −1 | K082725 | Graftguard Pressure Controlling Syringe | Maquet Cardiovascular, LLC | 2008 | 1 |
| 0 (this device) | K110993 | Femchec Pressure Managemet Device | Femasys, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 2002 | 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? (3)
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 2…res. Page 1 of 3 510(k) Summary for the FemChecTM Pressure Management Device Predicate Devices: K020954 H/S Elliptosphere Procedure Tray K792134 Bonchek Vein Distention System, 200 mm Hg… | 2002 |
| * | K792134 | Bonchek-Shiley Vein Distention SystemSummary page 2…e 2 === 510(k) Summary for the FemChecTM Pressure Management Device Predicate Devices: K020954 H/S Elliptosphere Procedure Tray K792134 Bonchek Vein Distention System, 200 mm Hg K082725 VasoShield Pressure Controlling Syringe… | 1979 |
| * | K082725 | Graftguard Pressure Controlling SyringeSummary page 2…vice Predicate Devices: K020954 H/S Elliptosphere Procedure Tray K792134 Bonchek Vein Distention System, 200 mm Hg K082725 VasoShield Pressure Controlling Syringe The FemChec is similar to the H/S Elliptosphere Procedure… | 2008 |
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?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 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 FemChec™ Pressure Management Device limits the maximum applied pressure while instilling contrast media into the uterus and fallopian tubes. It is to be used in conjunction with an intrauterine catheter for performance of hysterosalpingogram (HSG), such as tubal occlusion confirmation tests in women who have had tubal procedures for permanent female sterilization. The FemChec limits the applied intrauterine pressure to 200 mmHg.
The FemChec is provided with a fluid collector, stopcock, and intrauterine catheter for performing the HSG procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110993 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110993: Femchec Pressure Managemet Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110993
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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