510(k) · Cleared

Cleared

Vitalcare I.V. Administration Set

K050906510(k) TraditionalCleared Aug 23, 2005134-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

Vitalcare Group, Inc. · FPA Set, Administration, Intravascular

Cleared on Aug 23, 2005 as substantially equivalent to K925465 (Life Care Imaging, 1993) after a 134-day review. Its family tree reaches back 1 generation to 1993. 17 later devices descend from it.

Decided: Aug 23, 2005
Review: 134 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K925465 (1993). 17 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK925465 Teleradiology Device & Component of Pacs ComponentLife Care Imaging · 1993
This deviceK050906 Vitalcare I.V. Administration SetVitalcare Group, Inc. · 2005
Descendant · cites it directly · 7 of its ownK111351 Truecare Biomedix Intravascular Administration Set, Truecare…Us Infusion Dba Truecare Biomedix · 2011
Descendant · cites it directly · 7 of its ownK092715 Iroot BP PlusInnovative Bioceramix, Inc. · 2009
Descendant · 2 generations on · 4 of its ownK121803 Intravascular Administration SetActa Medical, LLC · 2012
Descendant · 2 generations on · 2 of its ownK102867 Iroot FSInnovative Bioceramix, Inc. · 2010
Descendant · 2 generations on · 1 of its ownK240365 Bioceramic Root Repair Material (C-Root BP)Beijing C-Root Dental Medical Devices Co., Ltd. · 2024

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2009high 4 (2023) · low 0 (2014)2026

Most influential descendants

Showing 5 of 17 · See all

K111351Truecare Biomedix Intravascular Administration Set, Truecare Biomedix Extension SetUs Infusion Dba Truecare Biomedix · 2011 · cites it directly7descendants
K092715Iroot BP PlusInnovative Bioceramix, Inc. · 2009 · cites it directly7descendants
K121803Intravascular Administration SetActa Medical, LLC · 2012 · 2 generations on4descendants
K102867Iroot FSInnovative Bioceramix, Inc. · 2010 · 2 generations on2descendants
K240365Bioceramic Root Repair Material (C-Root BP)Beijing C-Root Dental Medical Devices Co., Ltd. · 2024 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K925465	Teleradiology Device & Component of Pacs Component	Life Care Imaging	1993	—
0 (this device)	K050906	Vitalcare I.V. Administration Set	Vitalcare Group, Inc.	2005	—
+1	K111351	Truecare Biomedix Intravascular Administration Set, Truecare Biomedix…	Us Infusion Dba Truecare Biomedix	2011	—
+1	K092715	Iroot BP Plus	Innovative Bioceramix, Inc.	2009	—
+2	K121803	Intravascular Administration Set	Acta Medical, LLC	2012	—
+2	K102867	Iroot FS	Innovative Bioceramix, Inc.	2010	—
+2	K240365	Bioceramic Root Repair Material (C-Root BP)	Beijing C-Root Dental Medical Devices Co., Ltd.	2024	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	1	0
2011	1	0
2012	2	0
2013	1	0
2015	1	0
2017	1	0
2021	1	0
2022	1	0
2023	4	0
2024	2	0
2025	1	0

FIG. 1 — Lineage of K050906, 1993–2025Source: 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 FPA? 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

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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
*	K925465	Teleradiology Device & Component of Pacs Component Summary page 2 …e Detail Predicate K925465 Intended Use The VitalCare 3 in I IV Administration Set is used to Identical administer fluid…	Life Care Imaging	1993	—

What descends from it? (17)

See all 17

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K111351	Truecare Biomedix Intravascular Administration Set, Truecare Biomedix Extension Set	Us Infusion Dba Truecare Biomedix	2011	7
K092715	Iroot BP Plus	Innovative Bioceramix, Inc.	2009	7
K121511	Maclin Power Intravascular Administration Set	Maclin Power, Inc.	2013	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 no recall.
Of its descendants, K111351 (Us Infusion Dba Truecare Biomedix, 2011) has gone furthest, with 7 descendants of its own.

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 Intravascular Administration Set is a single use, sterile device that provides access for the administration of fluids from a container to the patients vascular system through the administration set's needle or catheter, which is inserted into a vein,

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050906 · printed Nov 4, 2026

Cite this page

510(k) Report. “K050906: Vitalcare I.V. Administration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050906

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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