510(k) · Cleared
Recalled · Class II · 2019Clearview Total
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinical Innovations, LLC · LKF Cannula, Manipulator/Injector, Uterine
Cleared on May 28, 2014 as substantially equivalent to K940681 (Clinical Innovations, Inc., 1994) and 2 other predicates after a 345-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it. It has been recalled once.
- Decided
- May 28, 2014
- Review
- 345 days
- Class
- Class II
- Product code
- LKF
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K955446 (1996). 4 ancestors in all, the oldest K940681 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK955446 Conmed Vcare Retractor/ElevatorConmedcorp · 1996 · Recalled
- 1 generation backK071907 Vcare Retractor/ElevatorConmed Corporation · 2007 · Recalled
- This deviceK131781 Clearview TotalClinical Innovations, LLC · 2014
- Descendant · cites it directly · 0 of its ownK172846 Uterine ManipulatorBeijing Hangtian Kadi Technology R&D Institute · 2018
Most influential descendants
Showing 1 of 1 · See all- K172846Uterine ManipulatorBeijing Hangtian Kadi Technology R&D Institute · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955446 | Conmed Vcare Retractor/Elevator | Conmedcorp | 1996 | 3 |
| −1 | K071907 | Vcare Retractor/Elevator | Conmed Corporation | 2007 | 4 |
| 0 (this device) | K131781 | Clearview Total | Clinical Innovations, LLC | 2014 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K940681 | Clearview Uterine ManipulatorSummary page 1…Tom Haueter Director, Quality Assurance and Regulatory Affairs 801-260-6028 T.Haueter(a&clinlicalinnovationis.coni Predicate Devices: Clinical Innovations ClearView® (K940681I) ConMed VCARE (K071907) The Koh Colpotomizer T m System (K95431 1) Device Description: Clinical Innovations' ClearView Total… | 1994 |
| * | K071907 | Vcare Retractor/ElevatorSummary page 1…ality Assurance and Regulatory Affairs 801-260-6028 T.Haueter(a&clinlicalinnovationis.coni Predicate Devices: Clinical Innovations ClearView® (K940681I) ConMed VCARE (K071907) The Koh Colpotomizer T m System (K95431 1) Device Description: Clinical Innovations' ClearView Total is a single-use sterile… | 2007 |
| * | K954311 | Koh Colpotomizer SystemSummary page 1…260-6028 T.Haueter(a&clinlicalinnovationis.coni Predicate Devices: Clinical Innovations ClearView® (K940681I) ConMed VCARE (K071907) The Koh Colpotomizer T m System (K95431 1) Device Description: Clinical Innovations' ClearView Total is a single-use sterile device used for uterine manipulation. Uterin… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172846 | Uterine Manipulator | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 30, 2019 | Class II | Z-2118-2020 | Process control | An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy cup. This may result in a delay in surgery and additional surgical… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 11.3 years on median.
- 4 of the 4 ancestors have a recall of any class.
- Of its descendants, K172846 (Beijing Hangtian Kadi Technology R&D Institute, 2018) has gone furthest, with 0 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. 2014, 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 ClearView Total is intended for use in laparoscopic procedures where it is desirable to delineate the vaginal fornices and the surgeon intends to remove or access intraperitoneal 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/K131781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131781: Clearview Total.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131781
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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