510(k) · Cleared

Recalled · Class II · 2022

Spinning Spiros, Model CH-2000

K082806510(k) SpecialCleared Apr 6, 2009194-day reviewClass II21 CFR 880.5440Recalls 5

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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

Cleared on Apr 6, 2009 as substantially equivalent to K070532 (Icu Medical, Inc., 2007) after a 194-day review. Its family tree reaches back 1 generation to 2007. 1 of the 14 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it. It has been recalled 5 times.

Decided: Apr 6, 2009
Review: 194 days
Class: Class II
Product code: FPA
Recalls: 5
Predicates: 1

Its longest line of descent runs back 1 generation to K070532 (2007). 12 later devices descend from it, 2 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK070532 SpirosIcu Medical, Inc. · 2007 · Recalled
This deviceK082806 Spinning Spiros, Model CH-2000Icu Medical, Inc. · 2009
Descendant · cites it directly · 10 of its ownK131549 Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · Recalled (Class I)
Descendant · 2 generations on · 9 of its ownK141448 Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015
Descendant · 3 generations on · 3 of its ownK192866 Chemfort CSTDSimplivia Healthcare, Ltd. · 2020 · Recalled
Descendant · 3 generations on · 1 of its ownK201422 Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC · 2021
Descendant · 3 generations on · 1 of its ownK180489 TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2018

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2011high 2 (2021) · low 0 (2012)2026

Class I recalls in this family

K131549 Chemolock, Chemolock Portcites it directly · 2013

Most influential descendants

Showing 5 of 12 · See all

K131549Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · cites it directly10descendants
K141448Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015 · 2 generations on9descendants
K192866Chemfort CSTDSimplivia Healthcare, Ltd. · 2020 · 3 generations on3descendants
K201422Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC · 2021 · 3 generations on1descendant
K180489TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2018 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K070532	Spiros	Icu Medical, Inc.	2007	1
0 (this device)	K082806	Spinning Spiros, Model CH-2000	Icu Medical, Inc.	2009	—
+1	K131549	Chemolock, Chemolock Port	Icu Medical, Inc.	2013	Class I
+2	K141448	Tevadaptor Closed Drug Reconstitution and Transfer System	Teva Medical Ltd., Migada Plant	2015	—
+3	K192866	Chemfort CSTD	Simplivia Healthcare, Ltd.	2020	1
+3	K201422	Arisure Closed System Drug Transfer Device (CSTD)	Yukon Medical, LLC	2021	—
+3	K180489	TEVADAPTOR Closed Drug Reconstitution and Transfer System	Teva Medical Ltd., Migada Plant	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2013	1	1
2015	1	0
2017	1	0
2018	1	0
2020	1	0
2021	2	0
2023	1	0
2024	1	0
2025	2	0

FIG. 1 — Lineage of K082806, 2007–2025Source: 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.

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 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
*	K070532	Spiros Summary page 1 …I.V. Administration Set, Accessory 21 CFR 880.5440, Class II Device Product Code: FPA .Legally Marketed Predicate Devices for Substantial Equivalence: *'K070532 - Spires - ICU Medical, Inc. Rationale for SE: The Spinning Spiros device is a passively closed - closed male luer or CML. This…	Icu Medical, Inc.	2007	1

Also cleared against K070532: 3 other devices →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K131549	Chemolock, Chemolock Port Class I	Icu Medical, Inc.	2013	10
K112636	Cytoguard (TM) Closed Luer Connector	B.Braun Medical, Inc.	2011	0

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 1, 2022	Class II	Z-1723-2022	Process control	Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Mar 16, 2021	Class II	Z-1567-2021	Component design/selection	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Mar 16, 2021	Class II	Z-1568-2021	Component design/selection	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Mar 16, 2021	Class II	Z-1569-2021	Component design/selection	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Aug 31, 2020	Class II	Z-0702-2021	Process control	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to…

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.

K131549Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K131549 (Icu Medical, Inc., 2013) has gone furthest, with 10 descendants of its own.
3 other devices also cite its predicate K070532.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Spiros is a single use, sterile, non-pyrogenic, swab-able, bidirectional valve device intended for use as an accessory to an Intravascular Administration Set. The Spiros provides access for the administration needle or catheter (which is inserted into the vein or artery).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082806 · printed Nov 4, 2026

Cite this page

510(k) Report. “K082806: Spinning Spiros, Model CH-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082806

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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