510(k) · Cleared
ClearedVialok Single Vial Access Device Vented
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yukon Medical, LLC · LHI Set, I.V. Fluid Transfer
Cleared on Aug 14, 2012 as substantially equivalent to K121182 (Yukon Medical, LLC, 2012) and 1 other predicate after a 15-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Aug 14, 2012
- Review
- 15 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K925401 (1993). 11 ancestors in all, the oldest K790472 (1979). No later device cites it as a predicate yet.
- Root · 3 generations backK925401 IV Fluid Transfer PinB. Braun of America, Inc. · 1993 · Recalled
- 2 generations backK983794 Chemo Mini Spike PlusB. Braun of America, Inc. · 1999
- 1 generation backK062482 Vented Vial Adapter Transfer DeviceMedimop Medical Projects, Ltd. · 2006
- This deviceK122265 Vialok Single Vial Access Device VentedYukon Medical, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925401 | IV Fluid Transfer Pin | B. Braun of America, Inc. | 1993 | 1 |
| −2 | K983794 | Chemo Mini Spike Plus | B. Braun of America, Inc. | 1999 | — |
| −1 | K062482 | Vented Vial Adapter Transfer Device | Medimop Medical Projects, Ltd. | 2006 | — |
| 0 (this device) | K122265 | Vialok Single Vial Access Device Vented | Yukon Medical, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2012 | 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 LHI? 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 LHI device
- #1 K252987 ADRx™ Admixture Devicescore 12.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K121182 | Vialok Non-VentedSummary page 2…following predicate device: Device Manufacturer 5 10O(k) Date Cleared ViaLokTM Yukon Medical K 121182 May 3, 2012 Non-vented Vented Vial Medimop Medical K062482 November 3, 2006… | 2012 |
| * | K062482 | Vented Vial Adapter Transfer DeviceSummary page 2…Date Cleared ViaLokTM Yukon Medical K 121182 May 3, 2012 Non-vented Vented Vial Medimop Medical K062482 November 3, 2006 Adapter Transfer Projects, LTD. Device 5.4. Device Description The Ven… | 2006 |
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 19 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 11 ancestors has a recall of any class.
How does its category compare?
All LHI devicesLHI Set, I.V. Fluid Transfer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LHI
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LHI
196in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHI
1in 2024
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · LHI
1,334in 2025
MAUDE reports naming product code LHI, 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 | 3 | 89 | 1 | 18 |
| 2008 | 4 | 154 | 3 | 27 |
| 2009 | 8 | 95 | 1 | 37 |
| 2010 | 5 | 139 | 3 | 49 |
| 2011 | 3 | 99 | 12 | 155 |
| 2012 | 5 | 127 | 0 | 529 |
| 2013 | 4 | 102 | 3 | 154 |
| 2014 | 6 | 63 | 0 | 155 |
| 2015 | 3 | 99 | 0 | 128 |
| 2016 | 3 | 159 | 1 (1) | 219 |
| 2017 | 5 | 56 | 1 | 536 |
| 2018 | 1 | — | 3 (3) | 1,499 |
| 2019 | 4 | 247 | 1 | 1,634 |
| 2020 | 3 | 189 | 0 | 1,171 |
| 2021 | 3 | 396 | 0 | 933 |
| 2022 | 6 | 278 | 2 | 1,834 |
| 2023 | 5 | 90 | 2 (2) | 1,047 |
| 2024 | 9 | 166 | 1 | 1,270 |
| 2025 | 6 | 196 | 0 | 1,334 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Vented Single Vial Access Device is a stand-alone, single-use, disposable device which permits access to a medication vial without the use of a needle. The device is intended for use by healthcare professionals in a wide variety of healthcare environments, including hospitals, healthcare facilities, and pharmacies.
The Vented Single Vial Access Device is indicated for use with standard medication vials and mating luer access devices for withdrawal and/or injection of fluid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122265 · printed Nov 4, 2026
Cite this page
510(k) Report. “K122265: Vialok Single Vial Access Device Vented.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122265
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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