# K051437: CML 1000

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Aug 3, 2005 after 63 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: 1 generation back to K970855 (1997). 1 ancestor in all.
16 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970855: Clave Connector, Icu Medical, Inc. (1997) Summary page 1.

## Most influential descendants
- K053049: Alaris Safety Male Luer (2006), 14 descendants of its own
- K071108: Texium Syringe (2007), 11 descendants of its own
- K083152: Equashield System (2009), 9 descendants of its own
- K091389: Equalshield Luer Lock Connector Pair (2009), 8 descendants of its own
- K101940: Equashield System Protective Plus (2010), 7 descendants of its own

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

Source page: https://510kreport.com/device/K051437
Methodology: https://510kreport.com/methodology