# K910584: One Step Button (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Technologies
- Decided: May 23, 1991 after 101 days
- Product code: KGC (Tube, Gastro-Enterostomy)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have 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
- K161003: EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector (2016), 1 descendant of its own
- K191844: Fidmi Low Profile Enteral Feeding Device (2019), 0 descendants of its own

## Recalls of this device
- Sep 11, 2015 · Class II · Z-0402-2016: Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices because they may cont
- Jun 2, 2005 · Not classified · Z-0962-05: Two blades may be heat staked onto the stiletto instead of the expected one blade.
- Jun 2, 2005 · Not classified · Z-0969-05: Two blades may be heat staked onto the stiletto instead of the expected one blade.
- Jun 2, 2005 · Not classified · Z-0972-05: Two blades may be heat staked onto the stiletto instead of the expected one blade.
- Jun 2, 2005 · Not classified · Z-0970-05: Two blades may be heat staked onto the stiletto instead of the expected one blade.
- Jun 2, 2005 · Not classified · Z-0971-05: Two blades may be heat staked onto the stiletto instead of the expected one blade.

Source page: https://510kreport.com/device/K910584
Methodology: https://510kreport.com/methodology