# K080007: Graduated Adapter with Clave

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: May 13, 2008 after 132 days
- Product code: EZD (Catheter, Straight)
- Device class: 2
- Regulation: 21 CFR 876.5130
- 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 K915571 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915571: Clave Connector, Icu Medical, Inc. (1992) Summary page 1.
- K970855: Clave Connector, Icu Medical, Inc. (1997) Summary page 1.
- K941190: Clave Needle-Less Connector Open Extension Set, Icu Medical, Inc. (1995) Summary page 1.
- K964435: Primary IV Set, Icu Medical, Inc. (1997) Summary page 1.
- K042182: Y Clave Connector with Integrated Check Valve, Model XI-3432, Icu Medical, Inc. (2004) Summary page 1.
- K041464: Busse Hospital Disposables Urethral Catheter, Busse Hospital Disposables (2004) Summary page 1.

## Indications for use
ICU Medical Graduated Adapter with Clave® is indicated as an accessory to a urinary catheter which facilitates the transfer of fluids into or out of the bladder via connection to the graduated adapter. This device for single procedure use only. Connection to catheter not to exceed 30 days.

Source page: https://510kreport.com/device/K080007
Methodology: https://510kreport.com/methodology