# MDM: Instrument, Manual, Surgical, General Use

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 44
- Recalls: 66 (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)
- 1992: 8
- 1993: 12
- 1994: 7
- 1995: 1
- 1998: 1
- 1999: 1
- 2001: 2
- 2002: 2
- 2005: 2
- 2008: 1

## Most-cited predicates
- K013040: Light Saber Introducer Needle (2001), cited by 2
- K911369: Qualtex Light Handle and Light Handle Cover (1991), cited by 1
- K924503: Personna Safety Scalpel (1993), cited by 1

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