# K982894: Mic-Key Glow Profile Gastrostomy Replacement Kit

- Pathway: 510(k) (Special)
- Applicant: Ballard Medical Products
- Decided: Sep 11, 1998 after 25 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.
No later device cites it as a predicate yet.
0 of 2 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 1.

## 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 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/K982894
Methodology: https://510kreport.com/methodology