510(k) · Cleared
Recalled · Class I · 2012Buretrol Solution Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · FPA Set, Administration, Intravascular
Cleared on Feb 19, 1999 after a 73-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 of the 6 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled 16 times, including 4 Class I recalls.
- Decided
- Feb 19, 1999
- Review
- 73 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 16 (4 Class I)
- Predicates
- 1
5 later devices descend from it, 2 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- This deviceK984381 Buretrol Solution SetsBaxter Healthcare Corp · 1999
- Descendant · cites it directly · 3 of its ownK023595 Burette-in Line (150 ML)Tuta Healthcare Pty Limited · 2002
- Descendant · 2 generations on · 0 of its ownK121511 Maclin Power Intravascular Administration SetMaclin Power, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK123874 Interlink System Buretrol Solution Sets, Interlink System Buretrol…Baxter Healthcare Corp · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK092905 Autostart BuretteAnalytica Pty, Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK032767 Lily Volume Meteric Administration Set, Models IB-2111 and Cib-120ESLily Medical Supplies Co., Ltd. · 2004
Most influential descendants
Showing 5 of 5 · See all- K023595Burette-in Line (150 ML)Tuta Healthcare Pty Limited · 2002 · cites it directly3descendants
- K121511Maclin Power Intravascular Administration SetMaclin Power, Inc. · 2013 · 2 generations on0descendants
- K123874Interlink System Buretrol Solution Sets, Interlink System Buretrol Solution Sets…Baxter Healthcare Corp · 2013 · cites it directly0descendants
- K092905Autostart BuretteAnalytica Pty, Ltd. · 2010 · 2 generations on0descendants
- K032767Lily Volume Meteric Administration Set, Models IB-2111 and Cib-120ESLily Medical Supplies Co., Ltd. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984381 | Buretrol Solution Sets | Baxter Healthcare Corp | 1999 | — |
| +1 | K023595 | Burette-in Line (150 ML) | Tuta Healthcare Pty Limited | 2002 | — |
| +2 | K121511 | Maclin Power Intravascular Administration Set | Maclin Power, Inc. | 2013 | — |
| +1 | K123874 | Interlink System Buretrol Solution Sets, Interlink System Buretrol Solution… | Baxter Healthcare Corp | 2013 | 3 |
| +2 | K092905 | Autostart Burette | Analytica Pty, Ltd. | 2010 | — |
| +2 | K032767 | Lily Volume Meteric Administration Set, Models IB-2111 and Cib-120ES | Lily Medical Supplies Co., Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 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.
1 device in this family has a Class I recall. 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K954391 | FDA’s K954391 is Models Qed-6, 6M and 6H Defibrillator Analyzer with Optional Universal… 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…ospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure 510(k) Premarket Notification Modified Buretrol® Sets K954391 510(k) Number: Not Available Device Name: Modified Buretrol ® Solution Sets Indication for Use: The Buretrol® Solution Sets w… | 1995 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 7, 2012 | Class I | Z-0012-2013 | Device Design | 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 the burette. |
| Sep 7, 2012 | Class I | Z-0013-2013 | Device Design | 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 the burette. |
| Sep 7, 2012 | Class I | Z-0015-2013 | Device Design | 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 the burette. |
| Sep 7, 2012 | Class I | Z-0014-2013 | Device Design | 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 the burette. |
| Sep 3, 2010 | Not classified | Z-0070-2011 | Employee error | 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 | Employee error | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 conditions. |
| Feb 28, 2005 | Not classified | Z-0845-05 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter. |
The 5 latest of 16 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023595 (Tuta Healthcare Pty Limited, 2002) has gone furthest, with 3 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?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984381 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984381: Buretrol Solution Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984381
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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