# K991653: Invision-Plus Injection Port Connector System

- Pathway: 510(k) (Traditional)
- Applicant: Rymed Technologies, Inc.
- Decided: Jun 24, 1999 after 42 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K942988 (1995). 4 ancestors in all.
31 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973167: Positive Pressure Connector, Icu Medical, Inc. (1997) Summary page 2.

## Most influential descendants
- K120443: Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated Device (2012), 28 descendants of its own
- K132413: MZ1000 (2013), 26 descendants of its own
- K140831: Maxzero Extension Set with Needless Connector (2014), 13 descendants of its own
- K170336: BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector (2017), 6 descendants of its own
- K183399: BD Nexiva Closed IV Catheter System (2019), 5 descendants of its own

## Recalls of this device
- Jan 5, 2016 · Class II · Z-0675-2016: Potential for the female luer component of the InVision-Plus IV connector to crack during use.
- May 25, 2006 · Not classified · Z-0319-2007: Weld failures on IV connector (area of female luer and spike body)
- May 25, 2006 · Not classified · Z-0320-2007: Weld failures on IV connector (area of female luer and spike body)
- May 25, 2006 · Not classified · Z-0321-2007: Weld failures on IV connector (area of female luer and spike body)

## Indications for use
The RyMed Technologies InVision-Plus™ Injection Port Systems are intended for single patient use in intravenous and blood administration sets without need for needles, thus eliminating the potential for needle-stick injuries during use.

Source page: https://510kreport.com/device/K991653
Methodology: https://510kreport.com/methodology