510(k) · Cleared
ClearedDiana ChemoClave Transfer Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icu Medical · ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Cleared on Oct 23, 2019 as substantially equivalent to K170110 (Icu Medical, Inc., 2018) after a 266-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Oct 23, 2019
- Review
- 266 days
- Class
- Class II
- Product code
- ONB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K903493 (1991). 8 ancestors in all, the oldest K894827 (1989). No later device cites it as a predicate yet.
- Root · 6 generations backK903493 Namic Contrast Savings Delivery SystemNorth American Instrument Corp. · 1991
- 5 generations backK961794 Fluid Administration Set - Contrast ManagerMerit Medical Systems, Inc. · 1996
- 4 generations backK022431 Medrad Transfer SetMedrad, Inc. · 2002
- 3 generations backK040456 Fleboset MultipleLaboratorios Grifols, S.A. · 2004
- 2 generations backK050339 Set Gri-Fill 3.0-1 Way, 2 Ways, MultipleLaboratorios Grifols, S.A. · 2005
- 1 generation backK170110 Diana Medication Transfer SetIcu Medical, Inc. · 2018 · Recalled
- This deviceK190157 Diana ChemoClave Transfer SetIcu Medical · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K903493 | Namic Contrast Savings Delivery System | North American Instrument Corp. | 1991 | — |
| −5 | K961794 | Fluid Administration Set - Contrast Manager | Merit Medical Systems, Inc. | 1996 | — |
| −4 | K022431 | Medrad Transfer Set | Medrad, Inc. | 2002 | — |
| −3 | K040456 | Fleboset Multiple | Laboratorios Grifols, S.A. | 2004 | — |
| −2 | K050339 | Set Gri-Fill 3.0-1 Way, 2 Ways, Multiple | Laboratorios Grifols, S.A. | 2005 | — |
| −1 | K170110 | Diana Medication Transfer Set | Icu Medical, Inc. | 2018 | 1 |
| 0 (this device) | K190157 | Diana ChemoClave Transfer Set | Icu Medical | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2003 | 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.
Planning a device in ONB? 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 |
|---|---|---|---|
| * | K170110 | Diana Medication Transfer SetSummary page 4…Transfer System Regulatory Class II Product Code: ONB III. PREDICATE DEVICE Predicate – K170110 Diana ChemoLock Transfer Set Reference – K173477 ChemoCLAVE Cytotoxic Medication Preparation and Delivery System (utilized… | 2018 |
| † | K173477 | ChemoCLAVE Cytotoxic Medication Preparation and Delivery System | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 5.4 years on median.
- 2 of the 8 ancestors have a recall of any class.
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. 2019, 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 Diana ChemoClave Transfer Set is a sterile, single-use closed system transfer device used for drug preparation to transfer drug from a drug vial to an IV bag for intravenous drug administration. It prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190157: Diana ChemoClave Transfer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190157
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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