510(k) · Cleared

Cleared

Burette-in Line (150 ML)

K023595510(k) TraditionalCleared Dec 18, 200251-day reviewClass II21 CFR 880.5440

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tuta Healthcare Pty Limited · FPA Set, Administration, Intravascular

Cleared on Dec 18, 2002 as substantially equivalent to K984381 (Baxter Healthcare Corp, 1999) after a 51-day review. Its family tree reaches back 1 generation to 1999. 1 of the 5 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.

Decided: Dec 18, 2002
Review: 51 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K984381 (1999). 3 later devices descend from it, 3 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK984381 Buretrol Solution SetsBaxter Healthcare Corp · 1999 · Recalled (Class I)
This deviceK023595 Burette-in Line (150 ML)Tuta Healthcare Pty Limited · 2002
Descendant · cites it directly · 0 of its ownK121511 Maclin Power Intravascular Administration SetMaclin Power, Inc. · 2013
Descendant · cites it directly · 0 of its ownK092905 Autostart BuretteAnalytica Pty, Ltd. · 2010
Descendant · cites it directly · 0 of its ownK032767 Lily Volume Meteric Administration Set, Models IB-2111 and Cib-120ESLily Medical Supplies Co., Ltd. · 2004

Class I recalls in this family

K984381 Buretrol Solution Setsdirect predicate · 1999

Most influential descendants

Showing 3 of 3 · See all

K121511Maclin Power Intravascular Administration SetMaclin Power, Inc. · 2013 · cites it directly0descendants
K092905Autostart BuretteAnalytica Pty, Ltd. · 2010 · cites it directly0descendants
K032767Lily Volume Meteric Administration Set, Models IB-2111 and Cib-120ESLily Medical Supplies Co., Ltd. · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K984381	Buretrol Solution Sets	Baxter Healthcare Corp	1999	Class I
0 (this device)	K023595	Burette-in Line (150 ML)	Tuta Healthcare Pty Limited	2002	—
+1	K121511	Maclin Power Intravascular Administration Set	Maclin Power, Inc.	2013	—
+1	K092905	Autostart Burette	Analytica Pty, Ltd.	2010	—
+1	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
2004	1	0
2010	1	0
2013	1	0

FIG. 1 — Lineage of K023595, 1999–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K984381	Buretrol Solution Sets Our reading of the summary gave K084381, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Baxter Healthcare’s In-Line Buretrol Extension Set”.	Baxter Healthcare Corp	1999	Class I

Also cleared against K984381: 1 other device →

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided
K121511	Maclin Power Intravascular Administration Set	Maclin Power, Inc.	2013
K092905	Autostart Burette	Analytica Pty, Ltd.	2010
K032767	Lily Volume Meteric Administration Set, Models IB-2111 and Cib-120ES	Lily Medical Supplies Co., Ltd.	2004

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K984381Buretrol Solution SetsBaxter Healthcare Corp · 1999 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls

What does this lineage say?

Its one ancestor has a recall, Class I.
Of its descendants, K121511 (Maclin Power, Inc., 2013) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K984381.

How does its category compare?

All FPA devices

FPA 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?

Administration of Intravenous fluids and drugs.

The Tuta Healthcare Pty. Burette In Line (150ml) is a device used to administer fluids from a container to a patient’s vascular system Through a cannula inserted into a vein.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023595 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023595: Burette-in Line (150 ML).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023595

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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