# K984381: Buretrol Solution Sets

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Feb 19, 1999 after 73 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 16 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K954391: Models Qed-6, 6M and 6H Defibrillator Analyzer with Optional Universal Pacemaker Load Adapter, Bio-Tek Instruments, Inc. (1995). Our OCR of the scanned summary read K954391, FDA’s number for Models Qed-6, 6M and 6H Defibrillator Analyzer with… (Bio-Tek Instruments, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Buretrol® Solution Sets”. Kept off the family tree. Summary page 5.

## Most influential descendants
- K023595: Burette-in Line (150 ML) (2002), 3 descendants of its own
- K121511: Maclin Power Intravascular Administration Set (2013), 0 descendants of its own
- K123874: Interlink System Buretrol Solution Sets, Interlink System Buretrol Solution Sets, Continued, Clearlink System Buretrol S (2013), 0 descendants of its own
- K092905: Autostart Burette (2010), 0 descendants of its own
- K032767: Lily Volume Meteric Administration Set, Models IB-2111 and Cib-120ES (2004), 0 descendants of its own

## Recalls of this device
- Sep 7, 2012 · Class I · Z-0012-2013: Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within t
- Sep 7, 2012 · Class I · Z-0013-2013: Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within t
- Sep 7, 2012 · Class I · Z-0015-2013: Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within t
- Sep 7, 2012 · Class I · Z-0014-2013: Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within t
- Sep 3, 2010 · Not classified · Z-0070-2011: There are leaks in the Drip Chamber Check Valve Subassembly of the Solution Set. A leak in a sterile pathway could allow microbial entry, which could lead to a blood stream infection.
- Nov 3, 2009 · Not classified · Z-0487-2010: The tubing may separate from the distal Clearlink Y-site of the set, which could result in patient injury if the separation occurs during patient use.
- Dec 15, 2005 · Not classified · Z-0654-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0655-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0656-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Mar 17, 2005 · Not classified · Z-0199-06: The Buretrol solution sets are currently labeled as acceptable for use with the Colleague Volumertric Pump, but there is a potential for a non-detection of an upstream occlusion under certain conditio
- Feb 28, 2005 · Not classified · Z-0845-05: Possible occlusion of the Clearlink injection site valve due to inadequate silicone lubrication of the slit in the upper seal of the valve.
- Apr 28, 2004 · Not classified · Z-0193-05: Inadequate directions for use may have contributed to an increase in infection rates at a small number of customers beginning use of the Clearlink needleless device.
- Oct 17, 2002 · Not classified · Z-0523-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Oct 17, 2002 · Not classified · Z-0504-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Oct 17, 2002 · Not classified · Z-0508-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Oct 17, 2002 · Not classified · Z-0510-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.

## Indications for use
The Buretrol® Solution Sets with the proposed burette chamber will have the same intended use as sets with the current design of this component. The intended use of these solution administration sets is the administration of fluids from a container into the patient’s vascular system through a vascular access device.

Source page: https://510kreport.com/device/K984381
Methodology: https://510kreport.com/methodology