# JOL: Catheter And Tip, Suction

- Device class: 2; regulation: 21 CFR 880.6740; FDA's rule: 510(k) exempt
- FDA decisions: 84
- Recalls: 7 (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)
- 1992: 2
- 1993: 2
- 1994: 16
- 1995: 6
- 1996: 1
- 1997: 1
- 1998: 4
- 2000: 1
- 2001: 3
- 2005: 1

## Most-cited predicates
- K003402: Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline for Device Irrigation (2001), cited by 2
- K933526: Sterile Water (1994), cited by 1
- K870572: Arrow-Clarke (TM) Pleura-Seal (TM) Thoracentesis Kit (1987), cited by 1
- K000265: Primary Care Solutions Sterile Water Device Irrigation (2001), cited by 1
- K943836: Pre-Filled 10CC Inflation Syringe W/Sterile Water (1994), cited by 1
- K903569: Curity Thoracentesis Tray (1990), cited by 1
- K943834: Sterile .9% Sodium Chloride Solution (1994), cited by 1
- K934382: Vci Suction/Irrigation Tubing Set (1994), cited by 1
- K000266: Primary Care Solutions Sterile Saline-0.9% Sodium Chloride for Device Irrigation (2001), cited by 1

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