# MIA: Needle, Spinal, Short Term

- Device class: 2; regulation: 21 CFR 868.5150; FDA's rule: 510(k) required
- FDA decisions: 10
- Recalls: 0 (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)
- 1993: 1
- 1994: 1
- 1996: 2
- 1997: 2
- 1998: 1
- 1999: 1
- 2005: 1
- 2018: 1

## Most-cited predicates
- K942442: Acufex T-Fix Delivery System (1994), cited by 3
- K983858: Spinal Anesthesia Needles and Introducer Needles (1999), cited by 2
- K904380: Spinal Cord Access Epidural Introducer System (1993), cited by 2
- K970997: Neo-Care Lumber Puncture Kit (1997), cited by 1
- K982269: Clear Hub Spinal Needle 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA and 27GA (1998), cited by 1
- K051860: Flexible Introducer Cannula, Model 135-1837 (2005), cited by 1

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