510(k) · Cleared

Cleared

Primary Symbiq Set, Dital Microbore Tubing, 0.2 Micron Filter, Non-Dehp

K121032510(k) SpecialCleared Jun 21, 201277-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

Hospira, Inc. · FPA Set, Administration, Intravascular

Cleared on Jun 21, 2012 as substantially equivalent to K110901 (Hospira, Inc., 2012) after a 77-day review. Its family tree reaches back 4 generations to 2001. 3 of the 7 devices in its family, counting itself, have a Class I recall.

Decided: Jun 21, 2012
Review: 77 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K011442 (2001). 6 ancestors in all. No later device cites it as a predicate yet. 3 of the 7 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 4 generations backK011442 Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · Recalled (Class I)
3 generations backK031185 Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play ModuleAbbott Laboratories · 2003 · Recalled
2 generations backK041550 Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 2004 · Recalled (Class I)
1 generation backK110901 Symbiq Infusion and Adminstration SetHospira, Inc. · 2012 · Recalled (Class I)
This deviceK121032 Primary Symbiq Set, Dital Microbore Tubing, 0.2 Micron Filter…Hospira, Inc. · 2012

Class I recalls in this family

K110901 Symbiq Infusion and Adminstration Setdirect predicate · 2012
K041550 Hospira Phoenix Infusion System with Hospira…2 generations back · 2004
K011442 Abbott Plum a+Infusion Pump, Model 119714 generations back · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K011442	Abbott Plum a+Infusion Pump, Model 11971	Abbott Laboratories	2001	Class I
−3	K031185	Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play Module	Abbott Laboratories	2003	4
−2	K041550	Hospira Phoenix Infusion System with Hospira Mednet Software	Abbott Laboratories	2004	Class I
−1	K110901	Symbiq Infusion and Adminstration Set	Hospira, Inc.	2012	Class I
0 (this device)	K121032	Primary Symbiq Set, Dital Microbore Tubing, 0.2 Micron Filter, Non-Dehp	Hospira, Inc.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0

FIG. 1 — Lineage of K121032, 2001–2012Source: 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.

3 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
*	K110901	Symbiq Infusion and Adminstration Set Summary page 1 …ce is claimed Valve, 2 CLAVET V-Sites, Distal Microbore Tubing, 0.2 Micron Filter, 105 Inch, Non-OEHP, List Number 16120 as cleared in K1 10901 on March 5,2012. Reason for 510(k) submission Labeling updates to reflect the qualifications o…	Hospira, Inc.	2012	Class I

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (3 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.

K110901Symbiq Infusion and Adminstration SetHospira, Inc. · 2012 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
K041550Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 2004 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
K011442Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
5 of the 6 ancestors have a recall of any class; 3 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. 2012, 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?

Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. They are intended primarily for use in the hospital setting and can be used in other acute and non-acute care areas, such as, but not limited to, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Sub acute Facilities, Outpatient/Surgical Centers, Long-term Care, Urgent Care, Transport, and Physician Offices.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121032 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121032: Primary Symbiq Set, Dital Microbore Tubing, 0.2 Micron Filter, Non-Dehp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121032

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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