# K021692: CLC2000 Catheter Patency Device

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Dec 4, 2003 after 561 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K942988 (1995). 4 ancestors in all.
29 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973167: Positive Pressure Connector, Icu Medical, Inc. (1997) Summary page 1.
- (no number) B.Braun Safsite: named in the summary without a submission number

## Most influential descendants
- K100434: Clave Neutron (2010), 28 descendants of its own
- K132413: MZ1000 (2013), 26 descendants of its own
- K140831: Maxzero Extension Set with Needless Connector (2014), 13 descendants of its own
- K170336: BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector (2017), 6 descendants of its own
- K183399: BD Nexiva Closed IV Catheter System (2019), 5 descendants of its own

## Indications for use
The CLC2000 is intended for use as an accessory to a vascular access device. The CLC2000 has been shown to reduce thrombotic occlusion within the internal catheter lumen and fibrin formation in an animal study. The CLC2000 is designed to assist in maintaining catheter patency. The CLC2000 does not require the use of needles and therefore will passively aid in the reduction of needlestick injuries.

Source page: https://510kreport.com/device/K021692
Methodology: https://510kreport.com/methodology