# K921370: Mic Gastro-Enterostomy Tube Modification

- Pathway: 510(k) (Traditional)
- Applicant: Medical Innovations Corp.
- Decided: May 2, 1994 after 773 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
1 of 12 devices in its family (counting itself) has a Class I recall.

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

## Most influential descendants
- K080253: Kimberly-Clark Introducer Kits (2008), 10 descendants of its own
- K093312: Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy Fasteners, Enternal Access Dilation System (2009), 5 descendants of its own
- K183057: PUMA-G System (2019), 2 descendants of its own
- K092049: Iyunni 3ID Tri-Funnel Gastrostomy Tube Kit (2009), 2 descendants of its own
- K223916: PUMA-G System (2023), 1 descendant of its own

## Recalls of this device
- Jan 16, 2024 · Class I · Z-1186-2024: MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
- Jan 16, 2024 · Class I · Z-1187-2024: MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.

Source page: https://510kreport.com/device/K921370
Methodology: https://510kreport.com/methodology