# K101270: Swabflsuh (3ML, 5ML, 10ML) Model 10331, 10351, 10311

- Pathway: 510(k) (Traditional)
- Applicant: Excelsior Medical Corp.
- Decided: Feb 10, 2011 after 280 days
- Product code: NGT (Saline, Vascular Access Flush)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K030467 (2003). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962938: Excelsior Disposable Syringe W/Normal Saline (.9% Sodium Chloride), Excelsior Medical Corp. (1996) Summary page 1.
- K082837: Sterile Field Saline Pre-Filled Syringe (S), Excelsior Medical Corp. (2008) Summary page 1.
- K083508: Swabcap, Excelsior Medical Corp. (2009) Summary page 1.

## Indications for use
The flush syringe is intended for flushing of IV catheters and IV tubing. SwabCap® is intended for use on a swab-able luer access valve as a disinfecting cleaner prior to line access and to act as a physical barrier to contamination between the line accesses. SwabCap® will disinfect the valve five (5) minutes after application and act as a physical barrier to contamination for up to ninety-six (96) hours under normal conditions if not removed. The SwabFlush product is provided as: 1. 10 ml fill in 10 ml saline flush syringe with integrated SwabCap®. 2. 5 ml fill in 10 ml saline flush syringe with integrated SwabCap®. 3. 3 ml fill in 10 ml saline flush syringe with integrated SwabCap®.

Source page: https://510kreport.com/device/K101270
Methodology: https://510kreport.com/methodology