510(k) · Cleared
ClearedUterine Manipulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Hangtian Kadi Technology R&D Institute · LKF Cannula, Manipulator/Injector, Uterine
Cleared on Jun 26, 2018 as substantially equivalent to K093556 (Conmed Corporation, 2010) and 1 other predicate after a 280-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Jun 26, 2018
- Review
- 280 days
- Class
- Class II
- Product code
- LKF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K955446 (1996). 6 ancestors in all, the oldest K940681 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK955446 Conmed Vcare Retractor/ElevatorConmedcorp · 1996 · Recalled
- 2 generations backK071907 Vcare Retractor/ElevatorConmed Corporation · 2007 · Recalled
- 1 generation backK131781 Clearview TotalClinical Innovations, LLC · 2014 · Recalled
- This deviceK172846 Uterine ManipulatorBeijing Hangtian Kadi Technology R&D Institute · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955446 | Conmed Vcare Retractor/Elevator | Conmedcorp | 1996 | 3 |
| −2 | K071907 | Vcare Retractor/Elevator | Conmed Corporation | 2007 | 4 |
| −1 | K131781 | Clearview Total | Clinical Innovations, LLC | 2014 | 1 |
| 0 (this device) | K172846 | Uterine Manipulator | Beijing Hangtian Kadi Technology R&D Institute | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2010 | 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? (2)
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 |
|---|---|---|---|
| * | K093556 | Vcare DXSummary page 5…the cup is available in four different sizes - 30mm, 35mm, 40mm and 46mm. Predicate Device Information: Predicate Device 1 for the HK-WQ Curved version: 510(k) Number: K093556 Trade Name: Vcare Dx Sponsor: Conmed Corporation Predicate Device 2 for the HK-ZQ Flexed version: 510(k) Number: K131781 Trade N… | 2010 |
| * | K131781 | Clearview TotalSummary page 5…1 for the HK-WQ Curved version: 510(k) Number: K093556 Trade Name: Vcare Dx Sponsor: Conmed Corporation Predicate Device 2 for the HK-ZQ Flexed version: 510(k) Number: K131781 Trade Name: Clearview Total Sponsor: Clinical Innovations The predicate devices have not been subject to a design related recall… | 2014 |
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 22 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- 5 of the 6 ancestors have a recall of any class.
How does its category compare?
All LKF devicesLKF Cannula, Manipulator/Injector, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 HK-WQ-I and HK-WQ-II are indicated for manipulation of the uterus, and injection of fluids during laparoscopic gynecologic procedures such as laparoscopic supracervical hysterectomy, minilap tubal ligation, laparoscopic tubal occlusion or diagnostic laparoscopy. The HK-ZQ-I and HK-ZQ-II are intended for use in laparoscopic procedures where it is desirable to delineate the vaginal fornices and the surgeon intends to remove or access intraperitonial…
Read the full statement (95 words)
The HK-WQ-I and HK-WQ-II are indicated for manipulation of the uterus, and injection of fluids during laparoscopic gynecologic procedures such as laparoscopic supracervical hysterectomy, minilap tubal ligation, laparoscopic tubal occlusion or diagnostic laparoscopy.
The HK-ZQ-I and HK-ZQ-II are intended for use in laparoscopic procedures where it is desirable to delineate the vaginal fornices and the surgeon intends to remove or access intraperitonial tissue through the vagina by use of a colpotomy or culdotomy incision; such as laparoscopically assisted vaginal hysterectomies, total laparoscopic hysterectomies, while maintaining pneumoperitoneum by sealing the vagina while a colpotomy is performed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172846 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172846: Uterine Manipulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172846
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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