510(k) · Cleared
Recalled · 2009IV Administration Sets with Needleless Access Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Venetec Intl., Inc. · FPA Set, Administration, Intravascular
Cleared on May 28, 1998 after a 72-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- May 28, 1998
- Review
- 72 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 2
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK980992 IV Administration Sets with Needleless Access DevicesVenetec Intl., Inc. · 1998
- Descendant · cites it directly · 1 of its ownK090134 Intravenous Power Injector Extension SetC.R. Bard, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK102405 Infusion Set for Powerpicc Solo 2 CatheterC.R. Bard, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK093489 IN Vision-Plus Nano with Neutral Advantage TechnologyRymed Technologies, Inc. · 2010 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K090134Intravenous Power Injector Extension SetC.R. Bard, Inc. · 2009 · cites it directly1descendant
- K102405Infusion Set for Powerpicc Solo 2 CatheterC.R. Bard, Inc. · 2011 · cites it directly0descendants
- K093489IN Vision-Plus Nano with Neutral Advantage TechnologyRymed Technologies, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980992 | IV Administration Sets with Needleless Access Devices | Venetec Intl., Inc. | 1998 | — |
| +1 | K090134 | Intravenous Power Injector Extension Set | C.R. Bard, Inc. | 2009 | — |
| +1 | K102405 | Infusion Set for Powerpicc Solo 2 Catheter | C.R. Bard, Inc. | 2011 | — |
| +2 | K093489 | IN Vision-Plus Nano with Neutral Advantage Technology | Rymed Technologies, Inc. | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 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 |
|---|---|---|---|---|
| Apr 2, 2009 | Not classified | Z-1539-2009 | Process control | The affected units may contain extension sets with the microbore tubing instead of extension sets with the macrobore tubing. |
| May 12, 2003 | Not classified | Z-0925-03 | Other | Set tubing disconnected from the male luer lock during use on patients. Misassembled. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K090134 (C.R. Bard, Inc., 2009) has gone furthest, with 1 descendant of its own.
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?
An extension set to be used as an extension to the Intravascular administration set used for fluid delivery. The IV extension set will connect the IV administration set to a catheter or needle inserted into a vessel. The IV extension set contains needleless access devices to protect the users from needle stick injuries.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980992: IV Administration Sets with Needleless Access Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980992
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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