# K922667: Mic Low Profile Gastrostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Medical Innovations Corp.
- Decided: Dec 1, 1993 after 597 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K993138: Ballard Mic-Key G Low Profile Gastrostomy Replacement Kit (1999), 5 descendants of its own
- 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

## Recalls of this device
- May 31, 2024 · Class II · Z-2422-2024: The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.

Source page: https://510kreport.com/device/K922667
Methodology: https://510kreport.com/methodology