510(k) · Cleared
Recalled · 2011Vcare Retractor/Elevator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Corporation · LKF Cannula, Manipulator/Injector, Uterine
Cleared on Oct 5, 2007 as substantially equivalent to K955446 (Conmedcorp, 1996) after an 87-day review. Its family tree reaches back 1 generation to 1996. 7 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 5, 2007
- Review
- 87 days
- Class
- Class II
- Product code
- LKF
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955446 (1996). 7 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK955446 Conmed Vcare Retractor/ElevatorConmedcorp · 1996 · Recalled
- This deviceK071907 Vcare Retractor/ElevatorConmed Corporation · 2007
- Descendant · cites it directly · 1 of its ownK142716 VCAREConmed Corporation · 2015
- Descendant · cites it directly · 1 of its ownK142164 Manipulator; Manipulator ProGynetech Pty., Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK131781 Clearview TotalClinical Innovations, LLC · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK220202 Uterine ElevatOR PRO with OccludOR BalloonThe O R Company Pty, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK172846 Uterine ManipulatorBeijing Hangtian Kadi Technology R&D Institute · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K142716VCAREConmed Corporation · 2015 · cites it directly1descendant
- K142164Manipulator; Manipulator ProGynetech Pty., Ltd. · 2014 · cites it directly1descendant
- K131781Clearview TotalClinical Innovations, LLC · 2014 · cites it directly1descendant
- K220202Uterine ElevatOR PRO with OccludOR BalloonThe O R Company Pty, Ltd. · 2022 · 2 generations on0descendants
- K172846Uterine ManipulatorBeijing Hangtian Kadi Technology R&D Institute · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955446 | Conmed Vcare Retractor/Elevator | Conmedcorp | 1996 | 3 |
| 0 (this device) | K071907 | Vcare Retractor/Elevator | Conmed Corporation | 2007 | — |
| +1 | K142716 | VCARE | Conmed Corporation | 2015 | — |
| +1 | K142164 | Manipulator; Manipulator Pro | Gynetech Pty., Ltd. | 2014 | — |
| +1 | K131781 | Clearview Total | Clinical Innovations, LLC | 2014 | 1 |
| +2 | K220202 | Uterine ElevatOR PRO with OccludOR Balloon | The O R Company Pty, Ltd. | 2022 | — |
| +2 | K172846 | Uterine Manipulator | Beijing Hangtian Kadi Technology R&D Institute | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K955446 | Conmed Vcare Retractor/ElevatorSummary page 1…I PROCODE: LKF Classification Panel: Obstetrics/Gynecology Panel Regulation Number: Unknown Predicate Device: K955446 VCARE® ConMed Corp. (Vaginal-Cervical Ahluwalia's… | 1996 |
What descends from it? (7)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 2, 2011 | Not classified | Z-1520-2011 | Device Design | Product manufactured after 4/11/2008, but before 8/01/2009, contains the earlier Instructions For Use, IFU (PN 17416, Rev. D) which does not contain the revisions on the addition of Warning Notes 10 and 11 and the expansion of Warning… |
| Sep 8, 2008 | Not classified | Z-0175-2009 | Process change control | The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retained in the vaginal canal had increased. |
| Sep 8, 2008 | Not classified | Z-0176-2009 | Process change control | The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retained in the vaginal canal had increased. |
| Sep 8, 2008 | Not classified | Z-0177-2009 | Process change control | The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retained in the vaginal canal had increased. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LKF devicesLKF Cannula, Manipulator/Injector, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 ConMed VCARE® Retractor/Elevator is indicated for manipulation of the uterus and injection of fluids or gases during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071907 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071907: Vcare Retractor/Elevator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071907
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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