# LKF: Cannula, Manipulator/Injector, Uterine

- Device class: 2; regulation: 21 CFR 884.4530; FDA's rule: 510(k) required
- FDA decisions: 87
- 510(k) review time 2021–2025: median 91 days (middle half 76–136)
- Recalls: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2013: 3
- 2014: 3
- 2015: 5
- 2016: 1
- 2017: 1
- 2018: 4
- 2019: 1
- 2022: 4
- 2024: 3
- 2025: 2

## Most-cited predicates
- K110288: Femvue Saline-Air Device (2011), cited by 4
- K071907: Vcare Retractor/Elevator (2007), cited by 4
- K071405: Probe Holder System (2007), cited by 3
- K083690: Femvue (TM) Catheter System (2009), cited by 3
- K013972: H/S Elliptosphere Catheter Set, Model 61-4005 (2001), cited by 3
- K955446: Conmed Vcare Retractor/Elevator (1996), cited by 2
- K141523: Ally Ups (2014), cited by 2
- K123258: The Advance Catheter for HSG and Sis (2013), cited by 2
- K953034: H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607) (1995), cited by 2
- K020951: H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007 (2002), cited by 2

Source page: https://510kreport.com/product-code/LKF
Data by year (CSV): https://510kreport.com/product-code/LKF.csv