# KNT: Tubes, Gastrointestinal (And Accessories)

- Device class: 2; regulation: 21 CFR 876.5980; FDA's rule: 510(k) required
- FDA decisions: 652
- 510(k) review time 2021–2025: median 110 days (middle half 55–175)
- Recalls: 235 (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)
- 2017: 9
- 2018: 7
- 2019: 10
- 2020: 5
- 2021: 6
- 2022: 7
- 2023: 5
- 2024: 9
- 2025: 4
- 2026: 3

## Most-cited predicates
- K130483: Boehringer Gastric Sizing Tube (2013), cited by 8
- K014297: Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile Button Replacement Gastrostomy Tube; Securi-T Initial P (2002), cited by 4
- K915171: Lopez Valve TM  II (1992), cited by 4
- K012113: Indwelling Fecal Management System (2002), cited by 4
- K023344: Indwelling Fecal Management System-Non-Sterile (2002), cited by 4
- K141631: Aquarius Extension Feeding Set (2014), cited by 3
- K821906: Corpak Enteric Feeding Tube W/Guide Tip (1982), cited by 3
- K905164: Tube Declogger (1991), cited by 3
- K043258: Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02 (2004), cited by 3
- K071764: Realize Gastric Calibration Tube, Models GCT180, GCT360 (2007), cited by 3

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