# KNQ: Dilator, Esophageal

- Device class: 2; regulation: 21 CFR 876.5365; FDA's rule: 510(k) exempt
- FDA decisions: 40
- Recalls: 20 (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)
- 1997: 2
- 1998: 1
- 1999: 2
- 2000: 2
- 2002: 1
- 2004: 2
- 2005: 1
- 2006: 3
- 2009: 3
- 2012: 1

## Most-cited predicates
- K031147: Optical DVS (Dual Vector Shearing) Esophageal Dilator (2004), cited by 2
- K993720: Cordis Maxi LD Large Diameter Balloon Dilatation Catheter (2000), cited by 2
- K851955: Savary-Gilliard Dilator (1985), cited by 2
- K023907: Cordis Maxi LD Large Diameter Balloon Dilatation Catheter, Cordis Maxi LD Pta Balloon Dilation Catheter (2002), cited by 2
- K974788: Cre (TM) Balloon Dilatation Catheter (1998), cited by 2
- K961438: Ballon Dilatation Catheter (1996), cited by 1
- K900924: Wilson-Cook Balloon Dilation Catheters (1990), cited by 1
- K061787: Maxforce TTS Single-Use Balloon Dilator (2006), cited by 1
- K971320: Cre Balloon Dilatation Catheter (1997), cited by 1
- K061937: Cook Endoscopy Esophageal Dilation Balloon (2006), cited by 1

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