510(k) · Cleared

Cleared

Blood/Solution Administration Set, Model 33.015

K023039510(k) TraditionalCleared Nov 7, 200256-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 · BRZ Set, Blood Transfusion

Cleared on Nov 7, 2002 as substantially equivalent to K924721 (Baxter Healthcare Corp, 1993) after a 56-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.

Decided: Nov 7, 2002
Review: 56 days
Class: Class II
Product code: BRZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K924721 (1993). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK924721 Baxter Solution Administration SetsBaxter Healthcare Corp · 1993 · Recalled
This deviceK023039 Blood/Solution Administration Set, Model 33.015Tuta Healthcare Pty Limited · 2002
Descendant · cites it directly · 1 of its ownK041496 Pentatrasfu Blood Transfusion SetsPentaferte S.P.A · 2005
Descendant · 2 generations on · 0 of its ownK083349 Blood Transfusion SetShan Dong Wei Gao Group Medical Polymer Products · 2009

Most influential descendants

Showing 2 of 2 · See all

K041496Pentatrasfu Blood Transfusion SetsPentaferte S.P.A · 2005 · cites it directly1descendant
K083349Blood Transfusion SetShan Dong Wei Gao Group Medical Polymer Products · 2009 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K924721	Baxter Solution Administration Sets	Baxter Healthcare Corp	1993	5
0 (this device)	K023039	Blood/Solution Administration Set, Model 33.015	Tuta Healthcare Pty Limited	2002	—
+1	K041496	Pentatrasfu Blood Transfusion Sets	Pentaferte S.P.A	2005	—
+2	K083349	Blood Transfusion Set	Shan Dong Wei Gao Group Medical Polymer Products	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2009	1	0

FIG. 1 — Lineage of K023039, 1993–2009Source: 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.

Planning a device in BRZ? 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 BRZ device

#1 K220558 Blood Administration Setsscore 4.7 · 2 generations · no Class I recall
#2 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
*	K924721	Baxter Solution Administration Sets Summary page 1 …alent Device The. BloodISolution Administration Set in the submission is substantially equivalent to Baxter Healthcare’s Solution Administration Set (K924721). The Tuta Healthcare Pty. Limited Blood Administration Set is a device used to administer fluids,blood and blood products fxom…	Baxter Healthcare Corp	1993	5

Also cleared against K924721: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K041496	Pentatrasfu Blood Transfusion Sets	Pentaferte S.P.A	2005	1

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K041496 (Pentaferte S.P.A, 2005) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K924721.

How does its category compare?

All BRZ devices

BRZ Set, Blood Transfusion: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BRZ

1in 2022

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BRZ

Too few BRZ 510(k)s in any year since 2007 to give a median.

Recalls per year · BRZ

No recall names BRZ since 2007.

Adverse event reports per year · BRZ

70in 2025

2007high 175 (2013) · low 12 (2007)2025

MAUDE reports naming product code BRZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	12
2008	1	—	12
2009	1	—	17
2010	0	—	71
2011	0	—	123
2012	0	—	141
2013	1	—	175
2014	0	—	108
2015	0	—	171
2016	0	—	78
2017	0	—	82
2018	0	—	66
2019	0	—	85
2020	0	—	90
2021	1	—	60
2022	1	—	55
2023	0	—	67
2024	0	—	89
2025	0	—	70
2026	0	—	—

What is it indicated for?

Administration of Intravenous fluids and drugs.

The Tuta Healthcare Ply. Limited Blood Administration Set is a device used to administer fluids, blood and blood products from a container to a patient's vascular system Through a catheter or venous access system inserted into a vein-

Use of Needle-Frce Access site may aide in the prevention of needlestick injury.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023039 · printed Nov 4, 2026

Cite this page

510(k) Report. “K023039: Blood/Solution Administration Set, Model 33.015.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023039

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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