# K980109: Cyclotech Cyclosporine Oral Solutions Dispenser

- Pathway: 510(k) (Traditional)
- Applicant: Sangstat Medical Corp.
- Decided: Aug 18, 1998 after 218 days
- Product code: KYX (Dispenser, Liquid Medication)
- Device class: 1
- Regulation: 21 CFR 880.6430
- 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 K801008 (1980). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K801008: Multi-AD Fluid Dispensing Pump MP-3000, Burron Medical Products, Inc. (1980) Summary page 1.

## Most influential descendants
- K143177: KleenGel Dispenser (2015), 0 descendants of its own

## Indications for use
The CycloTech™ Cyclosporine Oral Solution Dispenser (Dispenser) is intended to dispense SangCya™ cyclosporine oral solution USP (for microdispersion) as well as display and store dose size, time to next dose, remaining: available doses, and doses dispensed.

Source page: https://510kreport.com/device/K980109
Methodology: https://510kreport.com/methodology