# MQH: Microtools, Assisted Reproduction (Pipettes)

- Device class: 2; regulation: 21 CFR 884.6130; FDA's rule: 510(k) required
- FDA decisions: 27
- 510(k) review time 2021–2025: median 105 days (middle half 105–105)
- Recalls: 3 (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)
- 2008: 1
- 2010: 1
- 2011: 1
- 2014: 1
- 2015: 1
- 2016: 2
- 2017: 1
- 2020: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K041562: Cryotip (2004), cited by 4
- K012811: Blastomere Biopsy Micropipet, Polar Body Micropipet, Models 10-MBB,10-MBB-B,10-MPB,10-MPB-B (2002), cited by 3
- K990847: Intracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi Micropipets, Holding Micropipets, Assisted Hatching M (1999), cited by 3
- K161275: EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip (2017), cited by 2
- K993699: The Stripper (2000), cited by 2
- K983596: Intracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, Assisted Hatching (1999), cited by 1
- K033904: Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) (2004), cited by 1
- K033903: Modification to Intracytoplasmic Sperm Injection (Isci), Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, (2004), cited by 1
- K991700: Swemed Intracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes; Holding Pipttes; Denuding Pipettes; Assisted/ZO (1999), cited by 1
- K983713: Prodimed Microinjection Pipettes (1999), cited by 1

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