510(k) · Cleared

Cleared

Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm Luer Connector

K073339510(k) TraditionalCleared Mar 3, 200896-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

Fenwal, Inc. · BRZ Set, Blood Transfusion

Cleared on Mar 3, 2008 as substantially equivalent to K881321 (Baxter Healthcare Corp, 1988) and 1 other predicate after a 96-day review. Its family tree reaches back 1 generation to 1981. 3 later devices descend from it.

Decided: Mar 3, 2008
Review: 96 days
Class: Class II
Product code: BRZ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K811078 (1981). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK811078 Radiation Sterilized Admin. SetTravenol Laboratories, S.A. · 1981 · Recalled
This deviceK073339 Blood Component Recipient Set with Standard Size Filter and Infusion…Fenwal, Inc. · 2008
Descendant · cites it directly · 2 of its ownK111702 Amicus Separator System- Use in Therapeutic Plasma Exchange and…Fenwal, Inc. · 2012 · Recalled
Descendant · 2 generations on · 1 of its ownK141019 Amicus Separator System/ Amicus Seperator System;RefurbishedFenwal, Inc. · 2014
Descendant · 3 generations on · 0 of its ownK162462 AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,Llc · 2016

Most influential descendants

Showing 3 of 3 · See all

K111702Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus TpeFenwal, Inc. · 2012 · cites it directly2descendants
K141019Amicus Separator System/ Amicus Seperator System;RefurbishedFenwal, Inc. · 2014 · 2 generations on1descendant
K162462AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,Llc · 2016 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K811078	Radiation Sterilized Admin. Set	Travenol Laboratories, S.A.	1981	17
0 (this device)	K073339	Blood Component Recipient Set with Standard Size Filter and Infusion Set with…	Fenwal, Inc.	2008	—
+1	K111702	Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for…	Fenwal, Inc.	2012	1
+2	K141019	Amicus Separator System/ Amicus Seperator System;Refurbished	Fenwal, Inc.	2014	—
+3	K162462	AMICUS Separator System, AMICUS Separator System; Refurbished	Fresenius Kabi USA,Llc	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2014	1	0
2016	1	0

FIG. 1 — Lineage of K073339, 1981–2016Source: 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

Get a 510(k) Report

What was it cleared against? (2)

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
*	K881321	Blood/Solution Set W/Pressure Pump Summary page 1 …Name: Set, Blood Transfusion Classification Name: Intravascular Administration Set (21 CFR 880.5440) Legally Marketed Device: Blood/Solution Set with Pressure Pump (K881321) Radiation Sterilized Administration Sets (K811078) Fenwal Confidential…	Baxter Healthcare Corp	1988	8
*	K811078	Radiation Sterilized Admin. Set Summary page 1 …Intravascular Administration Set (21 CFR 880.5440) Legally Marketed Device: Blood/Solution Set with Pressure Pump (K881321) Radiation Sterilized Administration Sets (K811078) Fenwal Confidential Special 510(k)…	Travenol Laboratories, S.A.	1981	17

Also cleared against K881321: 1 other device →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K111702	Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus Tpe	Fenwal, Inc.	2012	2

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?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K111702 (Fenwal, Inc., 2012) has gone furthest, with 2 descendants of its own.
1 other device also cites its predicate K881321.

How does its category compare?

All BRZ devices

BRZ Set, Blood Transfusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?

Administration of blood and blood by-products.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K073339 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073339: Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm Luer Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073339

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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