# K093489: IN Vision-Plus Nano with Neutral Advantage Technology

- Pathway: 510(k) (Traditional)
- Applicant: Rymed Technologies, Inc.
- Decided: Jul 29, 2010 after 261 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K942988 (1995). 16 ancestors in all.
No later device cites it as a predicate yet.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991653: Invision-Plus Injection Port Connector System, Rymed Technologies, Inc. (1999) Summary page 1.
- K081289: V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device, Baxter Healthcare Corp (2008) Summary page 1.
- K993691: Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous Catheter, Arrow Intl., Inc. (2000) Summary page 3.
- K090134: Intravenous Power Injector Extension Set, C.R. Bard, Inc. (2009) Summary page 3.

## Recalls of this device
- Jan 5, 2016 · Class II · Z-0676-2016: Potential for the female luer component of the InVision-Plus IV connector to crack during use.

## Indications for use
The RyMed Technologies 1nVision-PlusOCSTN1 with Neutral AdvantageTm Technology 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. The RyMed Technologies lnVision-Plus'CSTm with Neutral Advantage Tm Technology Injection Port contains silver ions and chiorhiexidine, which are intended to inhibit the growth of microorganisms on the treated surfaces of the device, which include the septum and the fluid path. The RyMed Technologies InVision-Plus"' CST"' with Neutral AdvantageTM. Technology Injection Port has been shown to be effective for 7 days against the following microorganisms: Acinelobacter baimiannji, Methicillin-resistant Staphylococcus auretus, Staphylococcus autrevis, Eseherichija coli, Candlida albicans, Kiebsiella pnumutoniae, Pseudoinonas aerughiosa, and Staphylococcns epidermidis. The subject device is not intended to treat existing infections. The device is not intended to have any effect on contaminated infusion solutions. Correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested. The lnV ision-Plus®CSTMt with Neutral AdvantageTM~ Technology Injection Port Systems may be used with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 mL/sec.

Source page: https://510kreport.com/device/K093489
Methodology: https://510kreport.com/methodology