# GBX: Catheter, Irrigation

- Device class: 1; regulation: 21 CFR 878.4200; FDA's rule: 510(k) exempt
- FDA decisions: 77
- Recalls: 41 (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)
- 1994: 12
- 1995: 6
- 1996: 6
- 1997: 3
- 1998: 1
- 2000: 1
- 2002: 1
- 2005: 2
- 2008: 1
- 2014: 1

## Most-cited predicates
- K082725: Graftguard Pressure Controlling Syringe (2008), cited by 3
- K852143: Hall Irrigation System (1985), cited by 3
- K000704: DMC Saphenous Vein Distention System (SVDS) (2000), cited by 3
- K844061: Microtek Irrigation System (1985), cited by 1
- K926408: Sil-Slip Flat Suction Drain (1994), cited by 1
- K043515: Graftsaver (2005), cited by 1
- K974233: Lysonix Irrigation System (1998), cited by 1
- K052286: Deutsch Anti-Blockage Wound Drain (2005), cited by 1
- K973703: Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound Drain (1997), cited by 1
- K870704: Closed Paracentesis System W/Boasberg Catheter Set (1987), cited by 1

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