# K003402: Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline for Device Irrigation

- Pathway: 510(k) (Traditional)
- Applicant: Welcon, Inc.
- Decided: May 1, 2001 after 181 days
- Product code: JOL (Catheter And Tip, Suction)
- Device class: 2
- Regulation: 21 CFR 880.6740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K083042: Wound Flush, Sterile Water & Normal Saline (2008), 7 descendants of its own
- K161311: USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles (2016), 2 descendants of its own
- K173276: Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP (2018), 1 descendant of its own
- K172486: Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle (2017), 1 descendant of its own
- K243001: Sterile Water USP and Sterile 0.9% Normal Saline USP (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K003402
Methodology: https://510kreport.com/methodology