510(k) · Cleared
Recalled · 2003Intravascular Administration Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Kipp Group · FPA Set, Administration, Intravascular
Cleared on Aug 20, 1999 after a 73-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 21 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 20, 1999
- Review
- 73 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 2
- Predicates
- 0
21 later devices descend from it, 3 citing it directly.
- This deviceK991932 Intravascular Administration SetThe Kipp Group · 1999
- Descendant · cites it directly · 18 of its ownK051499 Intravascular Administration Set and Extension SetMedegen Medical Manufacturing Services · 2005 · Recalled
- Descendant · 2 generations on · 13 of its ownK140831 Maxzero Extension Set with Needless ConnectorCare Fusion · 2014
- Descendant · 3 generations on · 4 of its ownK162804 Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc. · 2017
- Descendant · 4 generations on · 3 of its ownK182897 Velano Vascular Q2 Extension SetVelano Vascular · 2019
- Descendant · 3 generations on · 3 of its ownK153293 Extension SetB.Braun Medical, Inc. · 2016 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K051499Intravascular Administration Set and Extension SetMedegen Medical Manufacturing Services · 2005 · cites it directly18descendants
- K140831Maxzero Extension Set with Needless ConnectorCare Fusion · 2014 · 2 generations on13descendants
- K162804Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc. · 2017 · 3 generations on4descendants
- K182897Velano Vascular Q2 Extension SetVelano Vascular · 2019 · 4 generations on3descendants
- K153293Extension SetB.Braun Medical, Inc. · 2016 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991932 | Intravascular Administration Set | The Kipp Group | 1999 | — |
| +1 | K051499 | Intravascular Administration Set and Extension Set | Medegen Medical Manufacturing Services | 2005 | 24 |
| +2 | K140831 | Maxzero Extension Set with Needless Connector | Care Fusion | 2014 | — |
| +3 | K162804 | Q2 Low Pressure Power Injection Extension Set | Quest Medical, Inc. | 2017 | — |
| +4 | K182897 | Velano Vascular Q2 Extension Set | Velano Vascular | 2019 | — |
| +3 | K153293 | Extension Set | B.Braun Medical, Inc. | 2016 | 8 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 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? (21)
See all 213 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 |
|---|---|---|---|---|
| Jun 9, 2003 | Not classified | Z-0956-03 | Other | The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin. |
| May 13, 2003 | Not classified | Z-0914-03 | Other | IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K051499 (Medegen Medical Manufacturing Services, 2005) has gone furthest, with 18 descendants 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?
Intravascular Administration Set and Extension Set is a device used to serve as a conduit for delivery of L.V. fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. Additional indications for use of this device is to provide multiple secondary sterile injection sites for other infusion fluids. The device may include a drip chamber with a hollow spike to penetrate and connect the tubing to an LV. bag or…
Read the full statement (128 words)
Intravascular Administration Set and Extension Set is a device used to serve as a conduit for delivery of L.V. fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. Additional indications for use of this device is to provide multiple secondary sterile injection sites for other infusion fluids. The device may include a drip chamber with a hollow spike to penetrate and connect the tubing to an LV. bag or other infusion fluid container, an infusiorr line filter, a 2 or 3 port manifold or LV. set stopcock, fluid delivery tubing, connectors between parts of the set, a Y-site injection site, a PRN injection site, a Y-site with integral check valve, a Spin-Loc connector and one or more Roller/Slide/Pinch clamps.
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/K991932 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991932: Intravascular Administration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991932
Report an extraction error
Are you the manufacturer?
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