510(k) · Cleared

Cleared

Blood Administration Sets

K220558510(k) TraditionalCleared Nov 17, 2022262-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 Nov 17, 2022 as substantially equivalent to K210335 (Baxter Healthcare Corporation, 2021) after a 262-day review. Its family tree reaches back 2 generations to 1999.

Decided: Nov 17, 2022
Review: 262 days
Class: Class II
Product code: BRZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K993120 (1999). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK993120 Modified Blood Recipient SetBaxter Healthcare Corp · 1999 · Recalled
1 generation backK210335 Blood Administration SetBaxter Healthcare Corporation · 2021
This deviceK220558 Blood Administration SetsBaxter Healthcare Corporation · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K993120	Modified Blood Recipient Set	Baxter Healthcare Corp	1999	10
−1	K210335	Blood Administration Set	Baxter Healthcare Corporation	2021	—
0 (this device)	K220558	Blood Administration Sets	Baxter Healthcare Corporation	2022	—

FIG. 1 — Lineage of K220558, 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 K210335 Blood Administration Setscore 4.5 · 1 generation · 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
*	K210335	Blood Administration Set Summary page 5 …3. Predicate Device Device Company Predicate 510(k) Clearance Date Blood Administration Baxter Healthcare K210335 June 10, 2021 Sets Corporation (Model 2N3383) REASON FOR SUBMISSION: The basis…	Baxter Healthcare Corporation	2021	—

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 21.6 years on median.
1 of the 2 ancestors has a recall of any class.

How does its category compare?

All BRZ devices

BRZ Set, Blood Transfusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?

Applicable to Product Code 2N3383: For the administration of blood, blood components or solutions from a container into the patient's vascular system through a vascular access device.

Applicable to Product Code 2N3385: For the administration of blood, blood components or solutions from a container into the patient's vascular system through a vascular access device. Only for use with Neonates and Pediatrics. Not for use in Trauma situations.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K220558 · printed Nov 4, 2026

Cite this page

510(k) Report. “K220558: Blood Administration Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220558

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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