510(k) · Cleared
Recalled · Class II · 2026Intravascular Administration Set and Extension Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medegen Medical Manufacturing Services · FPA Set, Administration, Intravascular
Cleared on Jun 22, 2005 as substantially equivalent to K991932 (The Kipp Group, 1999) after a 15-day review. Its family tree reaches back 1 generation to 1999. 18 later devices descend from it. It has been recalled 24 times.
- Decided
- Jun 22, 2005
- Review
- 15 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 24
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991932 (1999). 18 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK991932 Intravascular Administration SetThe Kipp Group · 1999 · Recalled
- This deviceK051499 Intravascular Administration Set and Extension SetMedegen Medical Manufacturing Services · 2005
- Descendant · cites it directly · 13 of its ownK140831 Maxzero Extension Set with Needless ConnectorCare Fusion · 2014
- Descendant · 2 generations on · 4 of its ownK162804 Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc. · 2017
- Descendant · 3 generations on · 3 of its ownK182897 Velano Vascular Q2 Extension SetVelano Vascular · 2019
- Descendant · 2 generations on · 3 of its ownK153293 Extension SetB.Braun Medical, Inc. · 2016 · Recalled
- Descendant · 4 generations on · 2 of its ownK200439 Velano ExT Extension SetVelano Vascular · 2021
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
2006high 3 (2017) · low 0 (2008)2026
Most influential descendants
Showing 5 of 18 · See all- K140831Maxzero Extension Set with Needless ConnectorCare Fusion · 2014 · cites it directly13descendants
- K162804Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc. · 2017 · 2 generations on4descendants
- K182897Velano Vascular Q2 Extension SetVelano Vascular · 2019 · 3 generations on3descendants
- K153293Extension SetB.Braun Medical, Inc. · 2016 · 2 generations on3descendants
- K200439Velano ExT Extension SetVelano Vascular · 2021 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991932 | Intravascular Administration Set | The Kipp Group | 1999 | 2 |
| 0 (this device) | K051499 | Intravascular Administration Set and Extension Set | Medegen Medical Manufacturing Services | 2005 | — |
| +1 | K140831 | Maxzero Extension Set with Needless Connector | Care Fusion | 2014 | — |
| +2 | K162804 | Q2 Low Pressure Power Injection Extension Set | Quest Medical, Inc. | 2017 | — |
| +3 | K182897 | Velano Vascular Q2 Extension Set | Velano Vascular | 2019 | — |
| +2 | K153293 | Extension Set | B.Braun Medical, Inc. | 2016 | 8 |
| +4 | K200439 | Velano ExT Extension Set | Velano Vascular | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 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 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 |
|---|---|---|---|
| * | K991932 | Intravascular Administration Set | 1999 |
What descends from it? (18)
See all 185 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 16, 2026 | Class II | Z-2941-2026 | Process control | Due to mechanical issue with internal sterilization equipment resulting in potential underdosing of product during processing, which may have resulted in products not being sterilized correctly. |
| Aug 1, 2022 | Class II | Z-1754-2022 | Error in labeling | Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks… |
| Aug 1, 2022 | Class II | Z-1759-2022 | Error in labeling | Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks… |
| Aug 1, 2022 | Class II | Z-1757-2022 | Error in labeling | Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks… |
| Aug 1, 2022 | Class II | Z-1758-2022 | Error in labeling | Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks… |
| Aug 1, 2022 | Class II | Z-1753-2022 | Error in labeling | Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks… |
| Aug 1, 2022 | Class II | Z-1755-2022 | Error in labeling | Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks… |
| Aug 1, 2022 | Class II | Z-1760-2022 | Error in labeling | Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks… |
| Aug 1, 2022 | Class II | Z-1752-2022 | Error in labeling | Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks… |
| Aug 1, 2022 | Class II | Z-1756-2022 | Error in labeling | Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks… |
| Feb 20, 2017 | Class II | Z-1482-2017 | Under Investigation by firm | CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter. |
| Feb 20, 2017 | Class II | Z-1464-2017 | Process control | CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing. |
| Jan 16, 2014 | Class II | Z-0931-2014 | Nonconforming Material/Component | CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they may have a defect in the trifurcated component that could result in a component leak. |
| Apr 18, 2012 | Class II | Z-0605-2013 | Nonconforming Material/Component | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating… |
| Apr 18, 2012 | Class II | Z-0596-2013 | Nonconforming Material/Component | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating… |
| Apr 18, 2012 | Class II | Z-0597-2013 | Nonconforming Material/Component | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating… |
| Apr 18, 2012 | Class II | Z-0599-2013 | Nonconforming Material/Component | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating… |
| Apr 18, 2012 | Class II | Z-0602-2013 | Nonconforming Material/Component | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating… |
| Apr 18, 2012 | Class II | Z-0603-2013 | Nonconforming Material/Component | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating… |
| Apr 18, 2012 | Class II | Z-0604-2013 | Nonconforming Material/Component | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating… |
| Apr 18, 2012 | Class II | Z-0598-2013 | Nonconforming Material/Component | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating… |
| Apr 18, 2012 | Class II | Z-0600-2013 | Nonconforming Material/Component | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating… |
| Apr 18, 2012 | Class II | Z-0601-2013 | Nonconforming Material/Component | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating… |
| Apr 20, 2011 | Not classified | Z-2707-2011 | Device Design | Carefusion has initiated a product recall for the MaxPlus bifuse extension set (minibore) needleless connectors Model MP9232-C as a result of a potential for occlusion. The product may be occluded at the bifused component. |
The 5 latest of 24 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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
2007high 23 (2010) · low 4 (2018)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
2007high 340 (2023) · low 75 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
2007high 166 (2009) · low 1 (2021)2026
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
2007high 47,210 (2024) · low 1,499 (2007)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 Intravascular Administration Set and Extension Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. The Intravascular Administration Set and Extension Set may incorporate componentry that aid in the prevention of accidental needle sticks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051499 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051499: Intravascular Administration Set and Extension Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051499
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