510(k) · Cleared

Cleared

Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set

K030467510(k) TraditionalCleared Mar 14, 200330-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

Iv Medical, Inc. · FPA Set, Administration, Intravascular

Cleared on Mar 14, 2003 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 of the 58 devices in its family, counting itself, have a Class I recall. 57 later devices descend from it.

Decided: Mar 14, 2003
Review: 30 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 0

57 later devices descend from it, 1 citing it directly. 5 of the 58 devices in this family, counting this one, have a Class I recall.

This deviceK030467 Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller…Iv Medical, Inc. · 2003
Descendant · cites it directly · 56 of its ownK063239 Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models…Hospira, Inc. · 2006 · Recalled
Descendant · 2 generations on · 30 of its ownK101677 Hospira Infusion Blood SetsHospira, Inc. · 2010 · Recalled (Class I)
Descendant · 2 generations on · 24 of its ownK080579 Effectiv (TM) CapHospira, Inc. · 2008
Descendant · 3 generations on · 23 of its ownK083508 SwabcapExcelsior Medical Corp. · 2009
Descendant · 3 generations on · 19 of its ownK113683 Lifeshield Vision Infusion Set with Pre-Pierced ResealHospira, Inc. · 2012

Showing 5 of 57 descendants. See all descendants

Descendants cleared per year

2006high 7 (2015) · low 0 (2007)2026

Class I recalls in this family

K101677 Hospira Infusion Blood Sets2 generations on · 2010
K141789 Plum 360 Infusion System with Hospira Mednet…3 generations on · 2015
K161469 Plum 360(TM) Infusion System with MedNet/ Smart…4 generations on · 2017
K223607 Plum Duo™ Infusion System5 generations on · 2023

Most influential descendants

Showing 5 of 57 · See all

K063239Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528, 17527, 17525 &…Hospira, Inc. · 2006 · cites it directly56descendants
K101677Hospira Infusion Blood SetsHospira, Inc. · 2010 · 2 generations on30descendants
K080579Effectiv (TM) CapHospira, Inc. · 2008 · 2 generations on24descendants
K083508SwabcapExcelsior Medical Corp. · 2009 · 3 generations on23descendants
K113683Lifeshield Vision Infusion Set with Pre-Pierced ResealHospira, Inc. · 2012 · 3 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K030467	Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set	Iv Medical, Inc.	2003	—
+1	K063239	Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528…	Hospira, Inc.	2006	7
+2	K101677	Hospira Infusion Blood Sets	Hospira, Inc.	2010	Class I
+2	K080579	Effectiv (TM) Cap	Hospira, Inc.	2008	—
+3	K083508	Swabcap	Excelsior Medical Corp.	2009	—
+3	K113683	Lifeshield Vision Infusion Set with Pre-Pierced Reseal	Hospira, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	1	0
2009	1	0
2010	2	1
2011	2	0
2012	6	0
2013	3	0
2014	5	0
2015	7	1
2016	5	0
2017	3	1
2019	1	1
2020	7	0
2021	2	0
2022	4	0
2023	1	1
2024	1	0
2025	2	0
2026	3	0

FIG. 1 — Lineage of K030467, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

5 devices in this family have 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

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (57)

See all 57

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

Number	Device	Applicant	Decided	Descendants
K063239	Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528, 17527, 17525 &…	Hospira, Inc.	2006	56

Has anything in its family been recalled? (5 Class I)

No FDA recall names this device.

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.

K101677Hospira Infusion Blood SetsHospira, Inc. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 18 Class I recalls
K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for Plum a+ Infusion…Hospira, Inc. · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
K223607Plum Duo™ Infusion SystemIcu Medical, Inc. · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 113 Class I recalls

What does this lineage say?

Of its descendants, K063239 (Hospira, Inc., 2006) has gone furthest, with 56 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?

GraviTechm is a single use, disposable gravitydriven flow regulator used in conjunction with I.V. administration sets and extension sets for controlling the flow rate of I.V. solutions into the human body-

GraviTechm Primary Sets are for use in cdntrolling the infusion rate of I.V. fluids from the solution bag to a patient catheter, which is inserted into a human vein.

GraviTech” Extension Sets are intended for use in conjunction with commonly used 1.V primary sets for conhlling the infusion mte of I.V. fluids into the human body.

Note: The use of any Needleless connector may aid in the prevention of needle stick injuries.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K030467 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030467: Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030467

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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