510(k) · Cleared
ClearedArisure Closed System Drug Transfer Device (CSTD)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yukon Medical, LLC · ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Cleared on Mar 2, 2021 as substantially equivalent to K141448 (Teva Medical Ltd., Migada Plant, 2015) after a 277-day review. Its family tree reaches back 9 generations to 1988. 3 of the 37 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Mar 2, 2021
- Review
- 277 days
- Class
- Class II
- Product code
- ONB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K883614 (1988). 35 ancestors in all. 1 later device descends from it, 1 citing it directly. 3 of the 37 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK883614 Cytoguard (R)Survival Technology, Inc. · 1988
- 5 generations between
- 3 generations backK123213 BD Phaseal Closed System Transfer DeviceBecton, Dickinson & CO · 2013 · Recalled
- 2 generations backK130197 BD Phaseal Closed System Transfer Device - P55Becton, Dickinson and Company · 2013 · Recalled
- 1 generation backK141448 Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015
- This deviceK201422 Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC · 2021
- Descendant · cites it directly · 0 of its ownK240517 ProSeal™ Vented Universal Vial AdaptorEpic Medical Pte., Ltd. · 2024
Show all 9 generations
- Root · 9 generations backK883614 Cytoguard (R)Survival Technology, Inc. · 1988
- 8 generations backK972527 Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting · 1997
- 7 generations backK980381 Phaseal, Closed System Forhandling of Parenteral Drugs, Additional…Carmel Pharma Ab. · 1998
- 6 generations backK023747 PhasealCarmel Pharma Ab. · 2002
- 5 generations backK110023 Infusion Adapter C100Carmel Pharma Ab. · 2011
- 4 generations backK120384 Protector, Injector, ConnectorBd Medical-Medical Surgical Systems · 2012
- 3 generations backK123213 BD Phaseal Closed System Transfer DeviceBecton, Dickinson & CO · 2013 · Recalled
- 2 generations backK130197 BD Phaseal Closed System Transfer Device - P55Becton, Dickinson and Company · 2013 · Recalled
- 1 generation backK141448 Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015
- This deviceK201422 Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC · 2021
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K240517ProSeal™ Vented Universal Vial AdaptorEpic Medical Pte., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K883614 | Cytoguard (R) | Survival Technology, Inc. | 1988 | — |
| −8 | K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic Agents | Quality System Consulting | 1997 | — |
| −7 | K980381 | Phaseal, Closed System Forhandling of Parenteral Drugs, Additional… | Carmel Pharma Ab. | 1998 | — |
| −6 | K023747 | Phaseal | Carmel Pharma Ab. | 2002 | — |
| −5 | K110023 | Infusion Adapter C100 | Carmel Pharma Ab. | 2011 | — |
| −4 | K120384 | Protector, Injector, Connector | Bd Medical-Medical Surgical Systems | 2012 | — |
| −3 | K123213 | BD Phaseal Closed System Transfer Device | Becton, Dickinson & CO | 2013 | 2 |
| −2 | K130197 | BD Phaseal Closed System Transfer Device - P55 | Becton, Dickinson and Company | 2013 | 1 |
| −1 | K141448 | Tevadaptor Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant | 2015 | — |
| 0 (this device) | K201422 | Arisure Closed System Drug Transfer Device (CSTD) | Yukon Medical, LLC | 2021 | — |
| +1 | K240517 | ProSeal™ Vented Universal Vial Adaptor | Epic Medical Pte., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 1 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 1 |
| 2009 | 3 | 0 |
| 2013 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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.
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 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 |
|---|---|---|---|
| * | K141448 | Tevadaptor Closed Drug Reconstitution and Transfer SystemSummary page 4…0 Regulatory Class: II Product Code: ONB III. PREDICATE DEVICE Name of Predicate: TEVADAPTOR® Closed Drug Reconstitution and Transfer System Predicate 510(k) Number: K141448 Regulation Number: 21 CFR 880.5440 Product Code: ONB This predicate has not been subject to a design-related recall. No reference… | 2015 |
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 |
|---|---|---|---|
| K240517 | ProSeal™ Vented Universal Vial Adaptor | 2024 | 0 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
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 · 2 generations back · ◆ in the 2013 ancestors bar of FIG. 12 Class I recalls
- K081361Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXXIcu Medical, Inc. · 2008 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 12 Class I recalls
- K964435Primary IV SetIcu Medical, Inc. · 1997 · 4 generations back · ◆ in the 1997 ancestors bar of FIG. 15 Class I recalls
What does this lineage say?
- The line of descent spans 33 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 12 of the 35 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K240517 (Epic Medical Pte., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K141448.
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. 2021, 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?
Arisure@ is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of drugs in vapor, aerosol or liquid form during preparation and administration, and prevents the introduction of microbial and airborne contaminants into the drug or fluid path, allowing the system to minimize exposure of individuals, healthcare personnel, and the environment to hazardous drugs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201422 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201422: Arisure Closed System Drug Transfer Device (CSTD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201422
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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