510(k) · Cleared
Recalled · Class II · 2026Diana Medication Transfer Set
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 10, 2018 as substantially equivalent to K050339 (Laboratorios Grifols, S.A., 2005) after a 575-day review. Its family tree reaches back 5 generations to 1991. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 10, 2018
- Review
- 575 days
- Class
- Class II
- Product code
- ONB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K903493 (1991). 7 ancestors in all, the oldest K894827 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK903493 Namic Contrast Savings Delivery SystemNorth American Instrument Corp. · 1991
- 4 generations backK961794 Fluid Administration Set - Contrast ManagerMerit Medical Systems, Inc. · 1996
- 3 generations backK022431 Medrad Transfer SetMedrad, Inc. · 2002
- 2 generations backK040456 Fleboset MultipleLaboratorios Grifols, S.A. · 2004
- 1 generation backK050339 Set Gri-Fill 3.0-1 Way, 2 Ways, MultipleLaboratorios Grifols, S.A. · 2005
- This deviceK170110 Diana Medication Transfer SetIcu Medical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK190157 Diana ChemoClave Transfer SetIcu Medical · 2019
Most influential descendants
Showing 1 of 1 · See all- K190157Diana ChemoClave Transfer SetIcu Medical · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K903493 | Namic Contrast Savings Delivery System | North American Instrument Corp. | 1991 | — |
| −4 | K961794 | Fluid Administration Set - Contrast Manager | Merit Medical Systems, Inc. | 1996 | — |
| −3 | K022431 | Medrad Transfer Set | Medrad, Inc. | 2002 | — |
| −2 | K040456 | Fleboset Multiple | Laboratorios Grifols, S.A. | 2004 | — |
| −1 | K050339 | Set Gri-Fill 3.0-1 Way, 2 Ways, Multiple | Laboratorios Grifols, S.A. | 2005 | — |
| 0 (this device) | K170110 | Diana Medication Transfer Set | Icu Medical, Inc. | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K050339 | Set Gri-Fill 3.0-1 Way, 2 Ways, MultipleSummary page 4…us Drug Reconstitution And Transfer System Regulatory Class II Product Code: ONB III. PREDICATE DEVICE Predicate – K050339 SETS GRI-FILL Reference – K131549 ChemoLock (utilized for vapor containment characteristics/methods) IV. DEVICE DESCRIPTION Diana… | 2005 |
| † | K131549 | Chemolock, Chemolock Port | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190157 | Diana ChemoClave Transfer Set | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K190157 (Icu Medical, 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K050339.
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 Diana ChemoLock 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/K170110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170110: Diana Medication 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/K170110
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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