# K043114: Kimberly-Clark Mic-Key Low Profile Gastrostomy Tube

- Pathway: 510(k) (Special)
- Applicant: Kimberly-Clark Corp.
- Decided: Dec 10, 2004 after 30 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K122653: Mic-Key SF Low Profile Gastrostomy Tube and Accessories (2013), 3 descendants of its own
- K161413: Low Profile Balloon Feeding Device (2017), 1 descendant of its own
- K222846: AMT G-Tube Balloon Gastrostomy Feeding Device (2023), 0 descendants of its own
- K173955: Mic-Key* SF Over-the-Wire Stoma Measuring Device (2018), 0 descendants of its own
- K142297: Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set (2015), 0 descendants of its own

## Indications for use
The MIC-KEY Low Profile Gastrostomy Tube is designed as replacement gastrostomy tube for use in a mature gastric stoma when a low profile device would benefit the patient. Gastrostomy tubes are indicated for patients with inability to swallow, other neurological disorders, and other conditions for which tube feeding would benefit the patient in the judgment of the physician..

Source page: https://510kreport.com/device/K043114
Methodology: https://510kreport.com/methodology