# MQF: Catheter, Assisted Reproduction

- Device class: 2; regulation: 21 CFR 884.6110; FDA's rule: 510(k) required
- FDA decisions: 53
- 510(k) review time 2021–2025: median 231 days (middle half 172–286)
- 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)
- 2015: 2
- 2017: 6
- 2018: 5
- 2019: 2
- 2020: 2
- 2022: 1
- 2023: 1
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K983594: Embryo Transfer Catheters/Sets (1998), cited by 6
- K990348: Wallace Trial Transfer Catheter, Model TT 1816N (1999), cited by 3
- K033084: Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter (2003), cited by 3
- K990350: Wallace Catheters-18CM, Model 1816; 23CM, Model 1816N; 23CM, Model 2316 (1999), cited by 3
- K162878: Kitazato ET Catheters (2017), cited by 2
- K172321: Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters (2017), cited by 2
- K092579: Intrauterine Insemination (Iui) Catheter (2010), cited by 2
- K983591: Intratubal Transfer Sets (1998), cited by 1
- K173686: Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter (2018), cited by 1
- K023382: Coopersurgical Malleable Sytlet (2002), cited by 1

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