510(k) · Cleared
Recalled · Class II · 2015Ally Ups
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CooperSurgical, Inc. · LKF Cannula, Manipulator/Injector, Uterine
Cleared on Nov 25, 2014 as substantially equivalent to K071405 (Intuitive Surgical, Inc., 2007) after a 169-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it. It has been recalled once.
- Decided
- Nov 25, 2014
- Review
- 169 days
- Class
- Class II
- Product code
- LKF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K941458 (1995). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK941458 Uterine Manipulator/Injector with SpringZinnanti Surgical Instruments, Inc. · 1995
- 1 generation backK071405 Probe Holder SystemIntuitive Surgical, Inc. · 2007
- This deviceK141523 Ally UpsCooperSurgical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK223064 ALLY II Uterine Positioning System™ (UPS)CooperSurgical, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK153092 Ally Uterine Positioning SystemCooperSurgical, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941458 | Uterine Manipulator/Injector with Spring | Zinnanti Surgical Instruments, Inc. | 1995 | — |
| −1 | K071405 | Probe Holder System | Intuitive Surgical, Inc. | 2007 | — |
| 0 (this device) | K141523 | Ally Ups | CooperSurgical, Inc. | 2014 | — |
| +1 | K223064 | ALLY II Uterine Positioning System™ (UPS) | CooperSurgical, Inc. | 2022 | — |
| +1 | K153092 | Ally Uterine Positioning System | CooperSurgical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K071405 | Probe Holder SystemSummary page 5…LKF Predicate Device(s): Intuitive Surgical “Probe Holder System, K071405 Device Description; The Cooper Surgical ALLY Uterine Positioning System™ (UPS) consists of a single multi- segmented, articul… | 2007 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 18, 2015 | Class II | Z-1727-2015 | Device Design | Design of device may expose user to injury to fingers or body parts |
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 12.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K223064 (CooperSurgical, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K071405.
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 Ally Uterine Positioning System™ (Ally UPS) is intended to assist the surgical staff in mounting, positioning, and holding uterine manipulators during gynecological laparoscopic procedures. It is intended for use by trained operating room personnel in an operating room environment.
The Adapter Drape for the Ally Uterine Positioning System™ (Ally UPS) is intended to assist the surgical staff in mounting, positioning, and holding uterine manipulators during gynecological laparoscopic procedures. It is intended for use by trained operating room personnel in an operating room environment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141523: Ally Ups.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141523
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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