# MQX: Needle, Acupuncture, Single Use

- Device class: 2; regulation: 21 CFR 880.5580; FDA's rule: 510(k) exempt
- FDA decisions: 91
- 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)
- 2006: 5
- 2007: 1
- 2008: 1
- 2009: 2
- 2010: 1
- 2011: 2
- 2013: 1
- 2014: 1
- 2015: 3
- 2017: 1

## Most-cited predicates
- K962809: Seirin Acupuncture Needles (1996), cited by 4
- K961339: Carbo Brand/Viva Brand Acupuncture Needles (1996), cited by 4
- K024207: Vinco Brand Acupuncture Needle (2003), cited by 2
- K003760: Tai-Chi Acupuncture Needles (2001), cited by 2
- K962419: CW-Disposable Acupuncture Needle (1996), cited by 2
- K052085: Standard, Special, Special+, Sneedle B-Type and Sneedle J-Type Acupuncture Needles (2005), cited by 2
- K972659: Dong Bang Acupuncture Needles (1997), cited by 2
- K970254: Seirin Pyonex Acupuncture Needles (1997), cited by 2
- K963769: Seirin Spinex Intradermal Acupuncture Needles (1996), cited by 2
- K963300: DBC Acupunture Needles (Several Types Are Described on the Following Pages) (1996), cited by 2

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