# MQE: Needle, Assisted Reproduction

- Device class: 2; regulation: 21 CFR 884.6100; FDA's rule: 510(k) required
- FDA decisions: 33
- 510(k) review time 2021–2025: median 241 days (middle half 229–254)
- Recalls: 1 (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)
- 2003: 4
- 2005: 1
- 2009: 1
- 2012: 1
- 2014: 1
- 2017: 4
- 2018: 1
- 2019: 3
- 2024: 2
- 2026: 1

## Most-cited predicates
- K983593: Ovum Pick-UP Aspiration Needles (1999), cited by 5
- K991273: Swemed Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer Needle (1999), cited by 3
- K082727: Follicle Aspiration Set, Reduced Single Lumen (2009), cited by 2
- K012068: Wallace Oocyte Retrieval Sets 16G, Wallace Oocyte Retrieval Set 17G, Models Meons 1633S, Meons 1733S (2001), cited by 1
- K191291: Wallace Dual Lumen Oocyte Recovery System (2019), cited by 1
- K112462: Kitazato Opu Needle (2012), cited by 1
- K031622: Wallace Dual Lumen Oocyte Retrieval Sets (2003), cited by 1
- K182959: Wallace Dual Lumen Oocyte Recovery System (2019), cited by 1

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