# K951489: Mri's All Silicone Gastrostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Manufacturing & Research, Inc.
- Decided: Jun 7, 1995 after 68 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.
8 later devices descend from it; 1 cites it directly.
0 of 9 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
- K962375: Microvasive Balloon Gastrostomy Tube Kit (1996), 7 descendants of its own
- K083685: Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285 (2009), 3 descendants of its own
- K130674: Entuit Thrive LP Balloon Retention Gastrostomy Feeding Tube (2014), 2 descendants of its own
- K083684: Endo Vive Standard Replacement Gastrostomy Tube, Model 82XX (2009), 2 descendants of its own
- K180708: Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX  Low Profile Gastrostomy Feeding Tube, PromaX  LP Patient Care Kit with ENFit (2018), 1 descendant of its own

Source page: https://510kreport.com/device/K951489
Methodology: https://510kreport.com/methodology