510(k) · Cleared
ClearedManipulatOR PRO, ManipulatOR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gynetech Pty., Ltd. · LKF Cannula, Manipulator/Injector, Uterine
Cleared on Aug 19, 2015 as substantially equivalent to K142164 (Gynetech Pty., Ltd., 2014) after a 170-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Aug 19, 2015
- Review
- 170 days
- Class
- Class II
- Product code
- LKF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K955446 (1996). 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 backK142164 Manipulator; Manipulator ProGynetech Pty., Ltd. · 2014
- This deviceK150519 ManipulatOR PRO, ManipulatORGynetech Pty., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K142164 | Manipulator; Manipulator ProSummary page 5…K150519 Pg. 2 of 4 Predicate Device: ManipulatOR and ManipulatOR PRO (K142164) Device Description: The ManipulatOR and ManipulatOR PRO are sterile, single-use uterine manipulators indicated for uterine mani… | 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 19 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- 2 of the 3 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. 2015, 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 ManipulatOR is indicated for manipulation of the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy (LAVH), laparoscopic tubal occlusion, and diagnostic laparoscopy. The ManipulatOR, when used together with the McCartney Tube, is indicated for manipulation of the uterus during laparoscopic procedures requiring maintenance of pneumoperitoneum, such as total laparoscopic hysterectomy (TLH). The ManipulatOR PRO is…
Read the full statement (96 words)
The ManipulatOR is indicated for manipulation of the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy (LAVH), laparoscopic tubal occlusion, and diagnostic laparoscopy. The ManipulatOR, when used together with the McCartney Tube, is indicated for manipulation of the uterus during laparoscopic procedures requiring maintenance of pneumoperitoneum, such as total laparoscopic hysterectomy (TLH).
The ManipulatOR PRO is indicated for manipulation of the uterus during laparoscopic procedures such as laparoscopic assisted vaginal hysterectomy (LAVH), total laparoscopic hysterectomy (TLH), laparoscopic tubal occlusion and diagnostic laparoscopy. The ManipulatOR PRO maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150519: ManipulatOR PRO, ManipulatOR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150519
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