# K961495: Huber Needle Extension Set with Standard Y-Injection Site, Interlink Y-Injection Site, Interlink T-Injection Site

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jun 26, 1996 after 69 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K950597 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950597: Core-Resistant Huber Infusion Set with Y-Site, Distronic Sterile Products, Inc. (1995) Summary page 1.
- (no number) Baxter Solution Administration Sets with InterLink® Injection Site: named in the summary without a submission number
- (no number) Baxter InterLink® T-Connector Extension Sets: named in the summary without a submission number

## Recalls of this device
- Aug 3, 2005 · Not classified · Z-1435-05: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Aug 3, 2005 · Not classified · Z-1432-05: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Aug 3, 2005 · Not classified · Z-1433-05: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Aug 3, 2005 · Not classified · Z-1439-05: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Aug 3, 2005 · Not classified · Z-1434-05: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Aug 3, 2005 · Not classified · Z-1436-05: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Aug 3, 2005 · Not classified · Z-1437-05: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Aug 3, 2005 · Not classified · Z-1438-05: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- May 31, 2005 · Not classified · Z-1048-05: Some of the product code 2N3709 extension sets with Y-injections sites were placed in packages labeled as product code 2N3703 extension sets which do not have Y-injection sites.

## Indications for use
Baxter’s proposed Huber Needle Extension Sets have the same intended use as the Micro-Med, Inc. Core Resistant Huber Infusion Sets covered by K950597. They are intended for the administration of solutions and drugs into vascular implant ports. The proposed Huber Needle Extension Sets with InterLink® Y-Site or InterLink® T-Site, like other products containing the InterLink® injection site are designed to reduce the tisk of accidental needle sticks when used in conjunction with the InterLink® cannula, as part of a “needleless” IV access system.

Source page: https://510kreport.com/device/K961495
Methodology: https://510kreport.com/methodology