510(k) · Cleared

Recalled · Class I · 2026

Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXX

K081361510(k) TraditionalCleared Aug 28, 2008105-day reviewClass II21 CFR 880.5440Recalls 7 (2 Class I)

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 Aug 28, 2008 as substantially equivalent to K970855 (Icu Medical, Inc., 1997) and 10 other predicates after a 105-day review. Its family tree reaches back 3 generations to 1998. 3 of the 30 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it. It has been recalled 7 times, including 2 Class I recalls.

Decided: Aug 28, 2008
Review: 105 days
Class: Class II
Product code: FPA
Recalls: 7 (2 Class I)
Predicates: 11

Its longest line of descent runs back 3 generations to K980580 (1998). 17 ancestors in all, the oldest K934561 (1994). 12 later devices descend from it, 2 citing it directly. 3 of the 30 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK980580 Becton Dickinson SyringesBd Becton Dickinson Vacutainer Systems Preanalytic · 1998
2 generations backK024052 Merit Medical 1-ML SyringeMerit Medical Systems, Inc. · 2003
1 generation backK070856 Icu Medical Single-Use SyringeIcu Medical, Inc. · 2007
This deviceK081361 Chemoclave Cytotoxic Medication Preparation and Delivery System…Icu Medical, Inc. · 2008
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

2013high 2 (2018) · low 0 (2014)2026

Class I recalls in this family

K964435 Primary IV Setdirect predicate · 1997
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
−3	K980580	Becton Dickinson Syringes	Bd Becton Dickinson Vacutainer Systems Preanalytic	1998	—
−2	K024052	Merit Medical 1-ML Syringe	Merit Medical Systems, Inc.	2003	—
−1	K070856	Icu Medical Single-Use Syringe	Icu Medical, Inc.	2007	—
0 (this device)	K081361	Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXX	Icu Medical, Inc.	2008	—
+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	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	3	0
1995	1	0
1997	2	1
1998	1	0
2000	2	0
2001	1	0
2003	1	0
2007	2	0
2008	1	0

Descendants by year cleared

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

FIG. 1 — Lineage of K081361, 1998–2025Source: 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.

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? (11)

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
*	K970855	Clave Connector Summary page 1 …lass II Device Product Codes: Primary Code - LHI, Secondary Code - FPA Legally Marketed Predicate Devices for Substantial Equivalence: Clave Connector - K970855 Chemo Dispensing Pin - K024239 *Genie - K070633 TM…	Icu Medical, Inc.	1997	52
*	K024239	Chemo Dispensing Pin, Model 12495 Summary page 1 …HI, Secondary Code - FPA Legally Marketed Predicate Devices for Substantial Equivalence: Clave Connector - K970855 Chemo Dispensing Pin - K024239 Genie - K070633 TM Chemo-AIDE - K003730 *Clave Vial Access Spike…	Abbott Laboratories	2003	—
*	K070633	Genie, Model CH-200 Summary page 1 …e - FPA Legally Marketed Predicate Devices for Substantial Equivalence: Clave Connector - K970855 Chemo Dispensing Pin - K024239 Genie - K070633 TM Chemo-AIDE - K003730 *Clave Vial Access Spike- K934591…	Icu Medical, Inc.	2007	—
*	K003730	Chemo-Aide Dispensing Pin Summary page 1 …or - K970855 Chemo Dispensing Pin - K024239 Genie - K070633 TM Chemo-AIDE - K003730 Clave Vial Access Spike- K934591 Taxol Administration Set- K003513 SpirosT M - K070532…	Baxter Healthcare Corp	2000	—
*	K934591	Clave Vial Access Spike Summary page 1 …Chemo Dispensing Pin - K024239 Genie - K070633 TM Chemo-AIDE - K003730 Clave Vial Access Spike- K934591 Taxol Administration Set- K003513 SpirosT M - K070532 *Chemo Spike ILRec…	Icu Medical, Inc.	1994	—
*	K003513	Taxol Administration Set Summary page 1 …TM Chemo-AIDE - K003730 Clave Vial Access Spike- K934591 Taxol Administration Set- K003513 SpirosT M - K070532 Chemo Spike ILReconstitution Device - K974431 Universal Vial Access Spik…	Icu Medical, Inc.	2001	—
*	K070532	Spiros Summary page 1 …Chemo-AIDE - K003730 Clave Vial Access Spike- K934591 Taxol Administration Set- K003513 SpirosT M - K070532 Chemo Spike ILReconstitution Device - K974431 Universal Vial Access Spike - K080989 *Primary…	Icu Medical, Inc.	2007	1
*	K974431	Chemo-Spike II Reconstitution Device Summary page 1 …cess Spike- K934591 Taxol Administration Set- K003513 SpirosT M - K070532 Chemo Spike ILReconstitution Device - K974431 Universal Vial Access Spike - K080989 Primary IV Set - K964435 Single Use Syringe - K070856 Rationale for SE: The ChemoCLAVE C…	Medi-Dose, Inc.	1998	—
*	K080989	Universal Vial Access Spike Summary page 1 …Taxol Administration Set- K003513 SpirosT M - K070532 Chemo Spike ILReconstitution Device - K974431 Universal Vial Access Spike - K080989 Primary IV Set - K964435 Single Use Syringe - K070856 Rationale for SE: The ChemoCLAVE Cytotoxic Medication Preparation and Del…	Icu Medical, Inc.	2008	1
*	K964435	Primary IV Set Summary page 1 …t- K003513 SpirosT M - K070532 Chemo Spike ILReconstitution Device - K974431 Universal Vial Access Spike - K080989 Primary IV Set - K964435 *Single Use Syringe - K070856 Rationale for SE: The ChemoCLAVE Cytotoxic Medication Preparation and Delivery Systems are a combin…	Icu Medical, Inc.	1997	Class I
*	K070856	Icu Medical Single-Use Syringe Summary page 1 …2 Chemo Spike ILReconstitution Device - K974431 Universal Vial Access Spike - K080989 Primary IV Set - K964435 Single Use Syringe - K070856 Rationale for SE: The ChemoCLAVE Cytotoxic Medication Preparation and Delivery Systems are a combination of ICU Medical devices t…	Icu Medical, Inc.	2007	—

Also cleared against K970855: 14 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
K173477	ChemoCLAVE Cytotoxic Medication Preparation and Delivery System	Icu Medical, Inc.	2018	0

Has anything in its family been recalled? (3 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 12, 2026	Class II	Z-3158-2026	Process control	Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid…
May 12, 2026	Class II	Z-3160-2026	Process control	Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration…
Mar 16, 2021	Class II	Z-1566-2021	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-1565-2021	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-0701-2021	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…
Feb 21, 2019	Class I	Z-1092-2019	Vendor change control	There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.
Feb 21, 2019	Class I	Z-1093-2019	Vendor change control	There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.

The 5 latest of 7 recalls; the web page lists all.

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 · ◆ in the 1997 ancestors bar of FIG. 15 Class I recalls
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?

The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
5 of the 17 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K131549 (Icu Medical, Inc., 2013) has gone furthest, with 10 descendants of its own.
14 other devices also cite its predicate K970855.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consists of 6 previously cleared components (CLAVE®, Spikes, SPIROSTM, GENIE TM, Vial Access, and Admin Sets) that can be combined into various configurations intended for use in the preparation and patient administration of cytotoxic medications.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081361 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081361: Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081361

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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