RyMed Technologies, LLC
Austin, TX, US
RyMed Technologies, LLC appears in FDA device records in Austin, TX. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for RyMed Technologies, LLC between 1996 and 2017. The busiest year on record is 1996, with 1. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1999 | 1 |
| 2010 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K162826 | Encore Neutral | FPA | Substantially Equivalent | |
| K093489 | IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY | FPA | Substantially Equivalent | |
| K991653 | INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM | FPA | Substantially Equivalent | |
| K960771 | SLAV AND SLAV-ONE INJECTION PORT CONNECTOR SYSTEM | FPA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005951712 | 3005951712 | RyMed Technologies, LLC | 6000 W. William Cannon Drive, Austin, TX 78749 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0676-2016 | InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposable, Single Use. Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use. | Potential for the female luer component of the InVision-Plus IV connector to crack during use. | Class II | Terminated | |
| Z-0675-2016 | InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use. | Potential for the female luer component of the InVision-Plus IV connector to crack during use. | Class II | Terminated | |
| Z-0321-2007 | RYM-5001 InVision-Plus Neutral Displacement I.V. Connector, packaged 100 units per box, 5 boxes per case (500 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies, Inc., Austin, TX. | Weld failures on IV connector (area of female luer and spike body) | Terminated | ||
| Z-0320-2007 | RYM-5000 InVision-Plus NEUTRAL I.V. Connector, packaged 200 units per box, 5 boxes per case (1000 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies, Inc., Austin, TX. | Weld failures on IV connector (area of female luer and spike body) | Terminated | ||
| Z-0319-2007 | RYM-5000 InVision-Plus Neutral Displacement I.V. Connector, packaged 200 units per box, 5 boxes per case (1000 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies, Inc., Austin, TX. | Weld failures on IV connector (area of female luer and spike body) | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain