# K993138: Ballard Mic-Key G Low Profile Gastrostomy Replacement Kit

- Pathway: 510(k) (Special)
- Applicant: Ballard Medical Products
- Decided: Oct 20, 1999 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
Longest line of descent: 1 generation back to K922667 (1993). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922667: Mic Low Profile Gastrostomy Tube, Medical Innovations Corp. (1993) Summary page 2.

## 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
- K041034: Skin Level Gastrostomy Tube Kit (Ecsl) (2004), 0 descendants of its own

## Indications for use
The MIC-KEY® G™ Low Profile Gastrostomy Replacement Kit is designed as a replacement Gastrostomy tube. It can be used in any well formed gastric tract where a low profile device is considered desirable. Gastrostomy tube feeding may be indicated for, patients needing long term enteral support, including but not limited to, feeding, hydrating, medication delivery, and decompressing, secondary to a primary condition relating to the head or neck. These conditions may include: Stroke Cancer Head or neck tumors, injuries, or trauma Neurological disorders resulting in a chewing or swallowing disorder.

Source page: https://510kreport.com/device/K993138
Methodology: https://510kreport.com/methodology