510(k) · Cleared
Recalled · Class II · 2016IN Vision-Plus Nano with Neutral Advantage Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rymed Technologies, Inc. · FPA Set, Administration, Intravascular
Cleared on Jul 29, 2010 as substantially equivalent to K991653 (Rymed Technologies, Inc., 1999) and 3 other predicates after a 261-day review. Its family tree reaches back 4 generations to 1995. 1 of the 17 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Jul 29, 2010
- Review
- 261 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 4 generations to K942988 (1995). 16 ancestors in all, the oldest K915571 (1992). No later device cites it as a predicate yet. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- 3 generations backK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996 · Recalled
- 2 generations backK973167 Positive Pressure ConnectorIcu Medical, Inc. · 1997
- 1 generation backK991653 Invision-Plus Injection Port Connector SystemRymed Technologies, Inc. · 1999 · Recalled
- This deviceK093489 IN Vision-Plus Nano with Neutral Advantage TechnologyRymed Technologies, Inc. · 2010
Class I recalls in this family
- K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…direct predicate · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K942988 | Filtered Extension Sets | B. Braun of America, Inc. | 1995 | 32 |
| −3 | K955585 | V2 Injection Site | B.Braun Medical, Inc. | 1996 | 27 |
| −2 | K973167 | Positive Pressure Connector | Icu Medical, Inc. | 1997 | — |
| −1 | K991653 | Invision-Plus Injection Port Connector System | Rymed Technologies, Inc. | 1999 | 4 |
| 0 (this device) | K093489 | IN Vision-Plus Nano with Neutral Advantage Technology | Rymed Technologies, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 1 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991653 | Invision-Plus Injection Port Connector SystemSummary page 1…Predicate Device [21 CFR 8D7.92(a)(3)J The following predicate devices have been identified: RyMed Technologies InVision-PluSTM1 Injection Ports - K991 653 The subject device issimilar to the RyMed Technologies lnViSionl-PIUSTM Injection Ports with regard to le… | 1999 |
| * | K081289 | V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial…Summary page 1…between the subject device and the untreated predicate device are outlined in Appendix 1. *Baxter V-Link Antimicrobial Luer Activated Device - K081289 The subject device is similar to the Baxter V-Link Antimicrobial Luer Activated Device except the subject… | 2008 |
| * | K993691 | Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterSummary page 3…predicate device is that the septum is treated with silver and chlorhexidine, and the fluid path is treated with silver. The predicate devices cleared under K08 1289 and K993691 contain silver and silver/chiorliexidine, respectively. The predicate device cleared under K090 134 is rated for use with low pre… | 2000 |
| * | K090134 | Intravenous Power Injector Extension SetSummary page 3…treated with silver. The predicate devices cleared under K08 1289 and K993691 contain silver and silver/chiorliexidine, respectively. The predicate device cleared under K090 134 is rated for use with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 mL/sec. Pe… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 5, 2016 | Class II | Z-0676-2016 | Process design | Potential for the female luer component of the InVision-Plus IV connector to crack during use. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · Direct predicate · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 11 of the 16 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K991653.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
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…
Read the full statement (188 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093489 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093489: IN Vision-Plus Nano with Neutral Advantage Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093489
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026