# KDD: Kit, Surgical Instrument, Disposable

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 62
- Recalls: 45 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1988: 1
- 1990: 1
- 1991: 5
- 1992: 4
- 1993: 6
- 1994: 1
- 1996: 1
- 1997: 1
- 2001: 1
- 2008: 1

## Most-cited predicates
- K821501: Sterile Tracheostomy Care Kit (1982), cited by 1
- K072814: Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic Procedures (2008), cited by 1
- K874063: Enteron Abdominal Paracentesis Tray (1987), cited by 1

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