510(k) · Cleared
Recalled · Class II · 2016Invision-Plus Injection Port Connector System
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 Jun 24, 1999 as substantially equivalent to K973167 (Icu Medical, Inc., 1997) after a 42-day review. Its family tree reaches back 3 generations to 1995. 31 later devices descend from it. It has been recalled 4 times.
- Decided
- Jun 24, 1999
- Review
- 42 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 3 generations to K942988 (1995). 4 ancestors in all. 31 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- 2 generations backK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996 · Recalled
- 1 generation backK973167 Positive Pressure ConnectorIcu Medical, Inc. · 1997
- This deviceK991653 Invision-Plus Injection Port Connector SystemRymed Technologies, Inc. · 1999
- Descendant · cites it directly · 28 of its ownK120443 Neutral Luer Activated Device and Extension Sets with Neutral Luer…Baxter Healthcare Corporation - Renal Division · 2012
- Descendant · 2 generations on · 26 of its ownK132413 MZ1000Care Fusion · 2013
- Descendant · 3 generations on · 13 of its ownK140831 Maxzero Extension Set with Needless ConnectorCare Fusion · 2014
- Descendant · 3 generations on · 6 of its ownK170336 BD Nexiva Closed IV Catheter System (Single Port) with MaxZero…Becton, Dickinson and Company · 2017
- Descendant · 4 generations on · 5 of its ownK183399 BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · Recalled
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K120443Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated DeviceBaxter Healthcare Corporation - Renal Division · 2012 · cites it directly28descendants
- K132413MZ1000Care Fusion · 2013 · 2 generations on26descendants
- K140831Maxzero Extension Set with Needless ConnectorCare Fusion · 2014 · 3 generations on13descendants
- K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless ConnectorBecton, Dickinson and Company · 2017 · 3 generations on6descendants
- K183399BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K942988 | Filtered Extension Sets | B. Braun of America, Inc. | 1995 | 32 |
| −2 | K955585 | V2 Injection Site | B.Braun Medical, Inc. | 1996 | 27 |
| −1 | K973167 | Positive Pressure Connector | Icu Medical, Inc. | 1997 | — |
| 0 (this device) | K991653 | Invision-Plus Injection Port Connector System | Rymed Technologies, Inc. | 1999 | — |
| +1 | K120443 | Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated… | Baxter Healthcare Corporation - Renal Division | 2012 | — |
| +2 | K132413 | MZ1000 | Care Fusion | 2013 | — |
| +3 | K140831 | Maxzero Extension Set with Needless Connector | Care Fusion | 2014 | — |
| +3 | K170336 | BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless… | Becton, Dickinson and Company | 2017 | — |
| +4 | K183399 | BD Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2019 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 6 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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.
Planning a device in FPA? 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? (1)
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 |
|---|---|---|---|
| * | K973167 | Positive Pressure ConnectorSummary page 2…ted Device Predicate Device Trade Name INVISION-PLUS™ Injection Port ICU Medical CLC2000™ Manufacturer RyMed Technologies ICU Medical, Inc 510 Number To be determined K973167 Intended Use Intravenous and blood Intravenous and blood administration administration Disposable for single patient use Yes Ye… | 1997 |
What descends from it? (31)
See all 313 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 5, 2016 | Class II | Z-0675-2016 | Process design | Potential for the female luer component of the InVision-Plus IV connector to crack during use. |
| May 25, 2006 | Not classified | Z-0319-2007 | Other | Weld failures on IV connector (area of female luer and spike body) |
| May 25, 2006 | Not classified | Z-0320-2007 | Other | Weld failures on IV connector (area of female luer and spike body) |
| May 25, 2006 | Not classified | Z-0321-2007 | Other | Weld failures on IV connector (area of female luer and spike body) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K120443 (Baxter Healthcare Corporation - Renal Division, 2012) has gone furthest, with 28 descendants of its own.
- 1 other device also cites its predicate K973167.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991653 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991653: Invision-Plus Injection Port Connector System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991653
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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