510(k) · Cleared

Cleared

Icu Medical Universal Single-Use Spikes

K082836510(k) SpecialCleared Feb 25, 2009152-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

Icu Medical, Inc. · FMG Stopcock, I.V. Set

Cleared on Feb 25, 2009 as substantially equivalent to K964435 (Icu Medical, Inc., 1997) after a 152-day review. Its family tree reaches back 1 generation to 1997. 1 of the 2 devices in its family, counting itself, has a Class I recall.

Decided: Feb 25, 2009
Review: 152 days
Class: Class II
Product code: FMG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K964435 (1997). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK964435 Primary IV SetIcu Medical, Inc. · 1997 · Recalled (Class I)
This deviceK082836 Icu Medical Universal Single-Use SpikesIcu Medical, Inc. · 2009

Class I recalls in this family

K964435 Primary IV Setdirect predicate · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K964435	Primary IV Set	Icu Medical, Inc.	1997	Class I
0 (this device)	K082836	Icu Medical Universal Single-Use Spikes	Icu Medical, Inc.	2009	—

FIG. 1 — Lineage of K082836, 1997–2009Source: 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 FMG device

#1 K242255 Qitexio® 4-Way Stopcock (QIT014)score 10.5 · 5 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
*	K964435	Primary IV Set Summary page 1 …uid transfer Classification Name: Set IV, Fluid transfer, 21 CFR 880.5440, Class II Device Legally Marketed Predicate Devices for Substantial Equivalence: K964435- IV Sets- ICU Medical, Inc. Rationale for SE: Spikes in this submission have a same intended use and materials as predicate de…	Icu Medical, Inc.	1997	Class I

Also cleared against K964435: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 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.

K964435Primary IV SetIcu Medical, Inc. · 1997 · Direct predicate · ◆ on the line of descent in FIG. 15 Class I recalls

What does this lineage say?

Its one ancestor has a recall, Class I.
4 other devices also cite its predicate K964435.

How does its category compare?

All FMG devices

FMG Stopcock, I.V. Set: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · FMG

1in 2025

2007high 2 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMG

Too few FMG 510(k)s in any year since 2007 to give a median.

Recalls per year · FMG

33in 2025

2007high 33 (2025) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FMG

868in 2025

2007high 935 (2024) · low 26 (2007)2025

MAUDE reports naming product code FMG, 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	2	—	5	26
2008	2	—	4	48
2009	2	—	0	27
2010	0	—	2	131
2011	0	—	8	95
2012	0	—	0	93
2013	2	—	0	117
2014	1	—	0	105
2015	0	—	0	96
2016	0	—	1	148
2017	0	—	2	114
2018	1	—	3	164
2019	2	—	0	400
2020	0	—	5	284
2021	0	—	0	245
2022	2	—	0	280
2023	2	—	0	689
2024	0	—	0	935
2025	1	—	33 (1)	868
2026	0	—	3	—

What is it indicated for?

Universal Spikes are used to build Intravascular Administration Sets which are Single Use, sterile, non-pyrogenic device and provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter inserted into a vein.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082836 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082836: Icu Medical Universal Single-Use Spikes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082836

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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