# K883718: Merit HI-Flex (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jan 30, 1989 after 152 days
- Product code: FPK (Tubing, Fluid Delivery)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 1 cites it directly.
0 of 15 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
- K051917: Diver C.E. Catheter (2005), 13 descendants of its own
- K071727: QXT Extraction Catheter (2007), 12 descendants of its own
- K072810: Pronto Low Profile (LP) Extraction Catheter, Model 5010 (2007), 11 descendants of its own
- K083784: Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010, Skyway RX Support Catheter, (2009), 10 descendants of its own
- K103405: Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto V4 Extraction 7F; Pronto V4 Extraction Cath (2010), 4 descendants of its own

## Recalls of this device
- Jun 5, 2025 · Class II · Z-2293-2025: High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped ai
- Mar 13, 2014 · Class II · Z-1319-2014: The products are labeled as sterile but were not sterilized.
- 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/K883718
Methodology: https://510kreport.com/methodology