# K915678: Merit Administration Set

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jul 30, 1992 after 224 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 14 (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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K955179: Contrast Media Set (1997), 1 descendant of its own
- K052252: Contrast Media Transfer Sets (2005), 0 descendants of its own

## Recalls of this device
- Aug 12, 2016 · Class II · Z-0649-2017: Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due to a molding defect in the drip chamber.
- Apr 8, 2008 · Not classified · Z-1807-2008: Convenience kits may contain non-filtered drip chambers
- Apr 8, 2008 · Not classified · Z-1801-2008: Convenience kits may contain non-filtered drip chambers
- Apr 8, 2008 · Not classified · Z-1802-2008: Convenience kits may contain non-filtered drip chambers
- Apr 8, 2008 · Not classified · Z-1804-2008: Convenience kits may contain non-filtered drip chambers
- Apr 8, 2008 · Not classified · Z-1803-2008: Convenience kits may contain non-filtered drip chambers
- Apr 8, 2008 · Not classified · Z-1805-2008: Convenience kits may contain non-filtered drip chambers
- Apr 8, 2008 · Not classified · Z-1800-2008: Convenience kits may contain non-filtered drip chambers.
- Apr 8, 2008 · Not classified · Z-1806-2008: Convenience kits may contain non-filtered drip chambers
- Apr 17, 2007 · Not classified · Z-0846-2007: Male luer in fluid administration sets may crack due to inadequate molding process
- Apr 17, 2007 · Not classified · Z-0847-2007: Male luer in fluid administration sets may crack due to inadequate molding process
- Apr 17, 2007 · Not classified · Z-0843-2007: Male luer in fluid administration sets may crack due to inadequate molding process
- Apr 17, 2007 · Not classified · Z-0844-2007: Male luer in fluid administration sets may crack due to inadequate molding process
- Apr 17, 2007 · Not classified · Z-0845-2007: Male luer in fluid administration sets may crack due to inadequate molding process

Source page: https://510kreport.com/device/K915678
Methodology: https://510kreport.com/methodology