510(k) · Cleared
ClearedUterine Manipulator/Injector with Spring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zinnanti Surgical Instruments, Inc. · LKF Cannula, Manipulator/Injector, Uterine
Cleared on Jan 25, 1995 after a 306-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Jan 25, 1995
- Review
- 306 days
- Class
- Class II
- Product code
- LKF
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK941458 Uterine Manipulator/Injector with SpringZinnanti Surgical Instruments, Inc. · 1995
- Descendant · cites it directly · 5 of its ownK071405 Probe Holder SystemIntuitive Surgical, Inc. · 2007
- Descendant · 2 generations on · 2 of its ownK141523 Ally UpsCooperSurgical, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK223064 ALLY II Uterine Positioning System™ (UPS)CooperSurgical, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK153092 Ally Uterine Positioning SystemCooperSurgical, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK130758 Kronner Side-Kick Uterine Manipulator HolderKronner Prototypes, Inc. · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K071405Probe Holder SystemIntuitive Surgical, Inc. · 2007 · cites it directly5descendants
- K141523Ally UpsCooperSurgical, Inc. · 2014 · 2 generations on2descendants
- K223064ALLY II Uterine Positioning System™ (UPS)CooperSurgical, Inc. · 2022 · 3 generations on0descendants
- K153092Ally Uterine Positioning SystemCooperSurgical, Inc. · 2015 · 3 generations on0descendants
- K130758Kronner Side-Kick Uterine Manipulator HolderKronner Prototypes, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941458 | Uterine Manipulator/Injector with Spring | Zinnanti Surgical Instruments, Inc. | 1995 | — |
| +1 | K071405 | Probe Holder System | Intuitive Surgical, Inc. | 2007 | — |
| +2 | K141523 | Ally Ups | CooperSurgical, Inc. | 2014 | 1 |
| +3 | K223064 | ALLY II Uterine Positioning System™ (UPS) | CooperSurgical, Inc. | 2022 | — |
| +3 | K153092 | Ally Uterine Positioning System | CooperSurgical, Inc. | 2015 | — |
| +2 | K130758 | Kronner Side-Kick Uterine Manipulator Holder | Kronner Prototypes, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K071405 (Intuitive Surgical, Inc., 2007) has gone furthest, with 5 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.
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 | — |
https://510kreport.com/device/K941458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941458: Uterine Manipulator/Injector with Spring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941458
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026