# KDQ: Bottle, Collection, Vacuum

- Device class: 2; regulation: 21 CFR 880.6740; FDA's rule: 510(k) exempt
- FDA decisions: 48
- Recalls: 11 (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)
- 1990: 3
- 1991: 2
- 1993: 1
- 1994: 1
- 1995: 1
- 1996: 3
- 1999: 1
- 2005: 1
- 2006: 1
- 2008: 1

## Most-cited predicates
- K905768: Pleur-Evac Chest Drainage Systems (1991), cited by 3
- K830671: Thorax-Klex Chest Drainage Unit (1983), cited by 3
- K962856: Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100, and S-2200 with Model S-100 Autotr (1996), cited by 2
- K043582: Ocean Chest Drain (2005), cited by 2
- K984496: Atrium Medical Corporation Express Chest Drain (1999), cited by 1

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