# K973167: Positive Pressure Connector

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Nov 17, 1997 after 84 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: 2 generations back to K942988 (1995). 3 ancestors in all.
35 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955585: V2 Injection Site, B.Braun Medical, Inc. (1996) Summary page 1.
- K970855: Clave Connector, Icu Medical, Inc. (1997) Summary page 1.

## Most influential descendants
- K991653: Invision-Plus Injection Port Connector System (1999), 31 descendants of its own
- K021692: CLC2000 Catheter Patency Device (2003), 29 descendants of its own
- K120443: Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated Device (2012), 28 descendants of its own
- K100434: Clave Neutron (2010), 28 descendants of its own
- K132413: MZ1000 (2013), 26 descendants of its own

## Indications for use
The CLC 2000 is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve intended for use as an accessory to Intravascular administration set. The CLC 2000 provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein or artery). The CLC 2000 also provides access for the withdrawal of fluids from a patient’s vascular system.

Source page: https://510kreport.com/device/K973167
Methodology: https://510kreport.com/methodology