# K051499: Intravascular Administration Set and Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Medegen Medical Manufacturing Services
- Decided: Jun 22, 2005 after 15 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 24 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K991932 (1999). 1 ancestor in all.
18 later devices descend from it; 5 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991932: Intravascular Administration Set, The Kipp Group (1999)

## Most influential descendants
- K140831: Maxzero Extension Set with Needless Connector (2014), 13 descendants of its own
- K162804: Q2 Low Pressure Power Injection Extension Set (2017), 4 descendants of its own
- K182897: Velano Vascular Q2 Extension Set (2019), 3 descendants of its own
- K153293: Extension Set (2016), 3 descendants of its own
- K200439: Velano ExT Extension Set (2021), 2 descendants of its own

## Recalls of this device
- Jun 16, 2026 · Class II · Z-2941-2026: 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: 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 compromi
- Aug 1, 2022 · Class II · Z-1759-2022: 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 compromi
- Aug 1, 2022 · Class II · Z-1757-2022: 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 compromi
- Aug 1, 2022 · Class II · Z-1758-2022: 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 compromi
- Aug 1, 2022 · Class II · Z-1753-2022: 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 compromi
- Aug 1, 2022 · Class II · Z-1755-2022: 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 compromi
- Aug 1, 2022 · Class II · Z-1760-2022: 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 compromi
- Aug 1, 2022 · Class II · Z-1752-2022: 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 compromi
- Aug 1, 2022 · Class II · Z-1756-2022: 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 compromi
- Feb 20, 2017 · Class II · Z-1482-2017: 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: 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: 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: 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,
- Apr 18, 2012 · Class II · Z-0596-2013: 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,
- Apr 18, 2012 · Class II · Z-0597-2013: 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,
- Apr 18, 2012 · Class II · Z-0599-2013: 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,
- Apr 18, 2012 · Class II · Z-0602-2013: 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,
- Apr 18, 2012 · Class II · Z-0603-2013: 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,
- Apr 18, 2012 · Class II · Z-0604-2013: 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,
- Apr 18, 2012 · Class II · Z-0598-2013: 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,
- Apr 18, 2012 · Class II · Z-0600-2013: 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,
- Apr 18, 2012 · Class II · Z-0601-2013: 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,
- Apr 20, 2011 · Not classified · Z-2707-2011: 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 

## Indications for use
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.

Source page: https://510kreport.com/device/K051499
Methodology: https://510kreport.com/methodology