510(k) · Cleared
ClearedSmartSite Vented Vial Access Device
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 Jul 31, 2015 as substantially equivalent to K052790 (Cardinal Health, Alaris Products, 2005) after a 15-day review. Its family tree reaches back 3 generations to 1990. 1 later device descends from it.
- Decided
- Jul 31, 2015
- Review
- 15 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K901063 (1990). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK901063 Luer Lock Transfer PinAcacia, Inc. · 1990
- 2 generations backK970485 Smartsite Access PinIvac Medical Systems · 1997 · Recalled
- 1 generation backK052790 Smartsite Vented Vial Access Device, Model TBDCardinal Health, Alaris Products · 2005
- This deviceK151963 SmartSite Vented Vial Access DeviceYukon Medical, LLC · 2015
- Descendant · cites it directly · 0 of its ownK243486 SmartSiteTM Vented Vial Access DeviceYukon Medical, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K243486SmartSiteTM Vented Vial Access DeviceYukon Medical, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K901063 | Luer Lock Transfer Pin | Acacia, Inc. | 1990 | — |
| −2 | K970485 | Smartsite Access Pin | Ivac Medical Systems | 1997 | 3 |
| −1 | K052790 | Smartsite Vented Vial Access Device, Model TBD | Cardinal Health, Alaris Products | 2005 | — |
| 0 (this device) | K151963 | SmartSite Vented Vial Access Device | Yukon Medical, LLC | 2015 | — |
| +1 | K243486 | SmartSiteTM Vented Vial Access Device | Yukon Medical, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
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.
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? (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 |
|---|---|---|---|
| * | K052790 | Smartsite Vented Vial Access Device, Model TBDSummary page 5…the following predicate device: Device Manufacturer 510(k) Date Cleared SmartSite® Vented Vial Cardinal Health, K052790 December, 23, Access Device Alaris Products 2005 5.4. Device Description The… | 2005 |
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 |
|---|---|---|---|
| K243486 | SmartSiteTM Vented Vial Access Device | 2024 | 0 |
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 25 years and passes through 4 companies; a new generation was cleared every 8.7 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K243486 (Yukon Medical, LLC, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K052790.
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. 2015, 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 SmartSite® Vented Vial Access Device is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® Vented Vial Access Device is indicated for use with standard rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151963 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151963: SmartSite Vented Vial Access Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151963
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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