# K070633: Genie, Model CH-200

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Jun 5, 2007 after 90 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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 K001368 (2000). 1 ancestor in all.
13 later devices descend from it; 1 cites it directly.
2 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001368: Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion Adapter, Carmel Pharma Ab. (2000)

## Most influential descendants
- K081361: Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXX (2008), 12 descendants of its own
- K131549: Chemolock, Chemolock Port (2013), 10 descendants of its own
- K141448: Tevadaptor Closed Drug Reconstitution and Transfer System (2015), 9 descendants of its own
- K192866: Chemfort CSTD (2020), 3 descendants of its own
- K201422: Arisure Closed System Drug Transfer Device (CSTD) (2021), 1 descendant of its own

## Indications for use
The Genie is an accessory to a syringe that provides a mean of sterile access to drug vials without the use of conventional needles (needleless). These devices are designed to improve user safety by reducing the exposure that health-care workers are subjected to regarding aerosolizing hazards and accidental needle sticks.

Source page: https://510kreport.com/device/K070633
Methodology: https://510kreport.com/methodology