510(k) · Cleared

Cleared

Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector

K213089510(k) SpecialCleared Nov 10, 202147-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

Ivenix, Inc. · FPA Set, Administration, Intravascular

Cleared on Nov 10, 2021 as substantially equivalent to K183311 (Ivenix, Inc., 2019) after a 47-day review. Its family tree reaches back 8 generations to 2001. 15 of the 38 devices in its family, counting itself, have a Class I recall.

Decided: Nov 10, 2021
Review: 47 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 1

Its longest line of descent runs back 8 generations to K011442 (2001). 37 ancestors in all, the oldest K780880 (1978). No later device cites it as a predicate yet. 15 of the 38 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 8 generations backK011442 Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · Recalled (Class I)
7 generations backK031185 Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play ModuleAbbott Laboratories · 2003 · Recalled
6 generations backK042081 Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3…Hospira, Inc. · 2004 · Recalled (Class I)
5 generations backK052052 Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3…Hospira, Inc. · 2005 · Recalled (Class I)
4 generations backK103224 Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe…Hospira, Inc. · 2011 · Recalled (Class I)
3 generations backK141789 Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play…Hospira, Inc. · 2015 · Recalled (Class I)
2 generations backK161469 Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play…Hospira, Inc. · 2017 · Recalled (Class I)
1 generation backK183311 Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · Recalled (Class I)
This deviceK213089 Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorIvenix, Inc. · 2021

Class I recalls in this family

K183311 Ivenix Infusion System (IIS)direct predicate · 2019
K173084 Spectrum IQ Infusion System, Dose IQ Safety…2 generations back · 2018
K161469 Plum 360(TM) Infusion System with MedNet/ Smart…2 generations back · 2017
K141789 Plum 360 Infusion System with Hospira Mednet…3 generations back · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K011442	Abbott Plum a+Infusion Pump, Model 11971	Abbott Laboratories	2001	Class I
−7	K031185	Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play Module	Abbott Laboratories	2003	4
−6	K042081	Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion…	Hospira, Inc.	2004	Class I
−5	K052052	Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump…	Hospira, Inc.	2005	Class I
−4	K103224	Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe Tubing	Hospira, Inc.	2011	Class I
−3	K141789	Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0…	Hospira, Inc.	2015	Class I
−2	K161469	Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module	Hospira, Inc.	2017	Class I
−1	K183311	Ivenix Infusion System (IIS)	Ivenix, Inc.	2019	Class I
0 (this device)	K213089	Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector	Ivenix, Inc.	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1978	1	0
1981	1	0
1990	1	0
1991	1	0
1994	2	0
1995	1	0
1999	1	0
2000	2	1
2001	1	1
2002	3	0
2003	3	0
2004	2	2
2005	2	0
2006	3	1
2010	2	1
2012	1	0
2014	1	1
2018	1	1

FIG. 1 — Lineage of K213089, 2001–2021Source: 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.

15 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

Get a 510(k) Report

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
*	K183311	Ivenix Infusion System (IIS) Summary page 4 …gulation Number: 21 CFR 880.5440 Product Codes: FPA Device Class: Class II Predicate Device: K183311 Ivenix Infusion System, Epidural Administration set with luer connector (SET-0016-1) Device…	Ivenix, Inc.	2019	Class I

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (15 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.

K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · Direct predicate · ◆ on the line of descent in FIG. 113 Class I recalls
K173084Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018 · 2 generations back · ◆ in the 2018 ancestors bar of FIG. 14 Class I recalls
K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 2017 · 2 generations back · ◆ on the line of descent in FIG. 12 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 back · ◆ on the line of descent in FIG. 12 Class I recalls
K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · 3 generations back · ◆ in the 2014 ancestors bar of FIG. 15 Class I recalls
K103224Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingHospira, Inc. · 2011 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K101677Hospira Infusion Blood SetsHospira, Inc. · 2010 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 18 Class I recalls
K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 13 Class I recalls
K042081Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with Hospira Mednet…Hospira, Inc. · 2004 · 4 generations back · ◆ on the line of descent in FIG. 14 Class I recalls
K060806Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model 13086; Pain Management, Model…Hospira, Inc. · 2006 · 5 generations back · ◆ in the 2006 ancestors bar of FIG. 17 Class I recalls
K052052Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump System, V11.5Hospira, Inc. · 2005 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K041550Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 2004 · 5 generations back · ◆ in the 2004 ancestors bar of FIG. 12 Class I recalls

Nearest 12 of 15 shown.

Nearest 5 of 15; all are on the web page.

What does this lineage say?

The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
28 of the 37 ancestors have a recall of any class; 15 have a Class I recall.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

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 Ivenix LVP Epidural Administration Set with NRFit Connector (SET-0030-1) is intended for the controlled administration of pharmaceutical drugs or other patient therapies via the epidural pathway. The Ivenix LVP Epidural Administration Set is intended only for use with the Ivenix Infusion System in a hospital or outpatient care environment.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K213089 · printed Nov 6, 2026

Cite this page

510(k) Report. “K213089: Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213089

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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