510(k) · Cleared
Recalled · Class II · 2026ChemoCLAVE Cytotoxic Medication Preparation and Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icu Medical, Inc. · ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Cleared on Aug 31, 2018 as substantially equivalent to K081361 (Icu Medical, Inc., 2008) after a 291-day review. Its family tree reaches back 4 generations to 1998. 2 of the 19 devices in its family, counting itself, have a Class I recall. It has been recalled 9 times.
- Decided
- Aug 31, 2018
- Review
- 291 days
- Class
- Class II
- Product code
- ONB
- Recalls
- 9
- Predicates
- 1
Its longest line of descent runs back 4 generations to K980580 (1998). 18 ancestors in all, the oldest K934561 (1994). No later device cites it as a predicate yet. 2 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK980580 Becton Dickinson SyringesBd Becton Dickinson Vacutainer Systems Preanalytic · 1998
- 3 generations backK024052 Merit Medical 1-ML SyringeMerit Medical Systems, Inc. · 2003
- 2 generations backK070856 Icu Medical Single-Use SyringeIcu Medical, Inc. · 2007
- 1 generation backK081361 Chemoclave Cytotoxic Medication Preparation and Delivery System…Icu Medical, Inc. · 2008 · Recalled (Class I)
- This deviceK173477 ChemoCLAVE Cytotoxic Medication Preparation and Delivery SystemIcu Medical, Inc. · 2018
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K980580 | Becton Dickinson Syringes | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | — |
| −3 | K024052 | Merit Medical 1-ML Syringe | Merit Medical Systems, Inc. | 2003 | — |
| −2 | K070856 | Icu Medical Single-Use Syringe | Icu Medical, Inc. | 2007 | — |
| −1 | K081361 | Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXX | Icu Medical, Inc. | 2008 | Class I |
| 0 (this device) | K173477 | ChemoCLAVE Cytotoxic Medication Preparation and Delivery System | Icu Medical, Inc. | 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 |
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.
2 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 ONB device
- #1 K240171 ProSeal™ Injector Plus (Model no. 421050)score 18.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K081361 | Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXXSummary page 4…0.5440 Product Code: ONB Device Class: Class II Primary Predicate Device: K081361 – ChemoCLAVE Cytotoxic Medication Preparation and Delivery… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 12, 2026 | Class II | Z-3159-2026 | 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-3161-2026 | 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-1578-2021 | 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-1579-2021 | 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-1580-2021 | 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-1576-2021 | 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-1577-2021 | 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-0704-2021 | 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… |
| Jul 6, 2020 | Class II | Z-0248-2021 | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. |
The 5 latest of 9 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.
- K081361Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXXIcu Medical, Inc. · 2008 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K964435Primary IV SetIcu Medical, Inc. · 1997 · 2 generations back · ◆ in the 1997 ancestors bar of FIG. 15 Class I recalls
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 6 of the 18 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K081361.
How does its category compare?
All ONB devicesONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · ONB
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONB
60in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONB
38in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · ONB
934in 2025
MAUDE reports naming product code ONB, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 3 | 58 | 0 | 2 |
| 2014 | 2 | — | 0 | 3 |
| 2015 | 3 | 235 | 0 | 4 |
| 2016 | 0 | — | 1 | 13 |
| 2017 | 2 | — | 0 | 66 |
| 2018 | 6 | 249 | 0 | 228 |
| 2019 | 1 | — | 1 (1) | 464 |
| 2020 | 3 | 213 | 4 | 442 |
| 2021 | 3 | 277 | 0 | 548 |
| 2022 | 1 | — | 1 | 448 |
| 2023 | 3 | 175 | 1 | 456 |
| 2024 | 8 | 102 | 1 | 686 |
| 2025 | 6 | 60 | 38 | 934 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173477: ChemoCLAVE Cytotoxic Medication Preparation and Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173477
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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