# K884913: Merit Intelliflator (TM) & Merit Monitor (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Apr 18, 1989 after 141 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K993341: Intellisystem II Color Monitor (1999), 2 descendants of its own
- K140943: Mastro Plus Balloon in-Deflation Device (2015), 0 descendants of its own
- K050753: Stryker Discmonitor (2005), 0 descendants of its own

## Recalls of this device
- Aug 19, 2024 · Class II · Z-0067-2025: Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
- Sep 29, 2009 · Not classified · Z-0513-2010: Potential sterility breach caused by excessive shipment damage.
- Sep 29, 2009 · Not classified · Z-0515-2010: Potential sterility breach caused by excessive shipment damage.
- Sep 29, 2009 · Not classified · Z-0512-2010: Potential sterility breach caused by excessive shipment damage.
- Sep 29, 2009 · Not classified · Z-0516-2010: Potential sterility breach caused by excessive shipment damage.
- Oct 1, 2003 · Not classified · Z-0138-04: There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or 

Source page: https://510kreport.com/device/K884913
Methodology: https://510kreport.com/methodology