# K913682: Merit Custom Kit

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Nov 15, 1991 after 88 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K152978: DeRoyal Angiography Kits (2016), 0 descendants of its own

## Recalls of this device
- Oct 25, 2010 · Not classified · Z-0557-2011: Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.
- Oct 25, 2010 · Not classified · Z-0558-2011: Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.
- Oct 25, 2010 · Not classified · Z-0559-2011: Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.
- Oct 25, 2010 · Not classified · Z-0552-2011: Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.
- Oct 25, 2010 · Not classified · Z-0553-2011: Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.
- Oct 25, 2010 · Not classified · Z-0554-2011: Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.
- Oct 25, 2010 · Not classified · Z-0555-2011: Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.
- Oct 25, 2010 · Not classified · Z-0556-2011: Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.
- Sep 29, 2009 · Not classified · Z-0510-2010: Potential sterility breach caused by excessive shipment damage.
- Sep 29, 2009 · Not classified · Z-0511-2010: Potential sterility breach caused by excessive shipment damage.
- Sep 12, 2008 · Not classified · Z-0578-2009: Leak, disposal bag: A Merit Disposal Depot (MDD) bag contained in certain custom waste management kits may leak. For further information, please contact Merit Medical Systems, Inc. by telephone at 801
- Sep 2, 2005 · Not classified · Z-0080-06: Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
- Sep 2, 2005 · Not classified · Z-0077-06: Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
- Sep 2, 2005 · Not classified · Z-0079-06: Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
- Sep 2, 2005 · Not classified · Z-0078-06: Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
- Sep 2, 2005 · Not classified · Z-0081-06: Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
- Feb 13, 2003 · Not classified · Z-0620-03: A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.
- Feb 13, 2003 · Not classified · Z-0621-03: A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.
- Feb 13, 2003 · Not classified · Z-0622-03: A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.

Source page: https://510kreport.com/device/K913682
Methodology: https://510kreport.com/methodology