510(k) · Cleared

Recalled · 2009

IV Administration Sets with Ultrablock UV-Resistant Tubing

K041490510(k) TraditionalCleared Oct 29, 2004147-day reviewClass II21 CFR 880.5440Recalls 1

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

B.Braun Medical, Inc. · FPA Set, Administration, Intravascular

Cleared on Oct 29, 2004 as substantially equivalent to K021480 (Codan US Corp., 2002) after a 147-day review. Its family tree reaches back 1 generation to 2002. 1 of the 11 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it. It has been recalled once.

Decided: Oct 29, 2004
Review: 147 days
Class: Class II
Product code: FPA
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K021480 (2002). 9 later devices descend from it, 1 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK021480 Extension Set Light-Safe, Model BC565Codan US Corp. · 2002
This deviceK041490 IV Administration Sets with Ultrablock UV-Resistant TubingB.Braun Medical, Inc. · 2004
Descendant · cites it directly · 8 of its ownK082182 AP 34 Multi-Therapy Infusion PumpQ-Core, Ltd. · 2008
Descendant · 2 generations on · 7 of its ownK123049 Sapphire Infusion PumpQ Core Medical, Ltd. · 2013
Descendant · 3 generations on · 3 of its ownK141389 Sapphire Infusion PumpQ Core Medical, Ltd. · 2014
Descendant · 4 generations on · 2 of its ownK161667 Sapphire Infusion PumpQ Core Medical, Ltd. · 2017
Descendant · 3 generations on · 1 of its ownK192860 Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · Recalled (Class I)

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2008high 2 (2014) · low 0 (2009)2026

Class I recalls in this family

K192860 Sapphire Infusion Pump, Sapphire administration…3 generations on · 2020

Most influential descendants

Showing 5 of 9 · See all

K082182AP 34 Multi-Therapy Infusion PumpQ-Core, Ltd. · 2008 · cites it directly8descendants
K123049Sapphire Infusion PumpQ Core Medical, Ltd. · 2013 · 2 generations on7descendants
K141389Sapphire Infusion PumpQ Core Medical, Ltd. · 2014 · 3 generations on3descendants
K161667Sapphire Infusion PumpQ Core Medical, Ltd. · 2017 · 4 generations on2descendants
K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K021480	Extension Set Light-Safe, Model BC565	Codan US Corp.	2002	—
0 (this device)	K041490	IV Administration Sets with Ultrablock UV-Resistant Tubing	B.Braun Medical, Inc.	2004	—
+1	K082182	AP 34 Multi-Therapy Infusion Pump	Q-Core, Ltd.	2008	—
+2	K123049	Sapphire Infusion Pump	Q Core Medical, Ltd.	2013	—
+3	K141389	Sapphire Infusion Pump	Q Core Medical, Ltd.	2014	—
+4	K161667	Sapphire Infusion Pump	Q Core Medical, Ltd.	2017	—
+3	K192860	Sapphire Infusion Pump, Sapphire administration sets	Q Core Medical, Ltd.	2020	Class I

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2013	1	0
2014	2	0
2016	1	0
2017	2	0
2020	1	1
2023	1	0

FIG. 1 — Lineage of K041490, 2002–2023Source: 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

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
*	K021480	Extension Set Light-Safe, Model BC565 Summary page 1 …COMMON OR USUAL Set, Administration Intravascular NAME: DEVICE Class II, 21 CFR §880.5440, CLASSIFICATION: Product Code: FPA PREDICATE DEVICE: K021480 Codan US Corporation Light-Safe Extension Set (BC565) and Abbott LifeShield® Primary Micr…	Codan US Corp.	2002	—
*	—	Abbott LifeShield® Primary Microbore Device Set Named without a submission number			—

Also cleared against K021480: 1 other device →

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K082182	AP 34 Multi-Therapy Infusion Pump	Q-Core, Ltd.	2008	8

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 24, 2009	Not classified	Z-0677-2010	Nonconforming Material/Component	System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the…

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.

K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K082182 (Q-Core, Ltd., 2008) has gone furthest, with 8 descendants of its own.
1 other device also cites its predicate K021480.

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?

The IV Administration Sets with Ultrablock UV-Resistant Tubing are intended for the

pump or gravity administration of IV fluids involving light sensitive solutions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041490 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041490: IV Administration Sets with Ultrablock UV-Resistant Tubing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041490

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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