510(k) · Cleared

Cleared

Blood Administration Set

K210335510(k) TraditionalCleared Jun 10, 2021125-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

Baxter Healthcare Corporation · BRZ Set, Blood Transfusion

Cleared on Jun 10, 2021 as substantially equivalent to K993120 (Baxter Healthcare Corp, 1999) after a 125-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.

Decided: Jun 10, 2021
Review: 125 days
Class: Class II
Product code: BRZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K993120 (1999). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK993120 Modified Blood Recipient SetBaxter Healthcare Corp · 1999 · Recalled
This deviceK210335 Blood Administration SetBaxter Healthcare Corporation · 2021
Descendant · cites it directly · 0 of its ownK220558 Blood Administration SetsBaxter Healthcare Corporation · 2022

Most influential descendants

Showing 1 of 1 · See all

K220558Blood Administration SetsBaxter Healthcare Corporation · 2022 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K993120	Modified Blood Recipient Set	Baxter Healthcare Corp	1999	10
0 (this device)	K210335	Blood Administration Set	Baxter Healthcare Corporation	2021	—
+1	K220558	Blood Administration Sets	Baxter Healthcare Corporation	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0

FIG. 1 — Lineage of K210335, 1999–2022Source: 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

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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
*	K993120	Modified Blood Recipient Set Summary page 5 …Table 2. Predicate Device Device Company Predicate 510(k) Clearance Date Blood Administration Baxter Healthcare K993120 November 17, 1999 Sets Corporation REASON FOR SUBMISSION: The basis for this premarket notifi…	Baxter Healthcare Corp	1999	10

Also cleared against K993120: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K220558	Blood Administration Sets	Baxter Healthcare Corporation	2022	0

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, K220558 (Baxter Healthcare Corporation, 2022) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K993120.

How does its category compare?

All BRZ devices

BRZ Set, Blood Transfusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

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?

For the administration of blood, blood components or solutions 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/K210335 · printed Nov 6, 2026

Cite this page

510(k) Report. “K210335: Blood Administration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210335

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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