510(k) · Cleared
ClearedSmartsite Vented Vial Access Device, Model TBD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health, Alaris Products · LHI Set, I.V. Fluid Transfer
Cleared on Dec 23, 2005 as substantially equivalent to K983794 (B. Braun of America, Inc., 1999) and 1 other predicate after an 81-day review. Its family tree reaches back 2 generations to 1990. 5 later devices descend from it.
- Decided
- Dec 23, 2005
- Review
- 81 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K901063 (1990). 6 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK901063 Luer Lock Transfer PinAcacia, Inc. · 1990
- 1 generation backK970485 Smartsite Access PinIvac Medical Systems · 1997 · Recalled
- This deviceK052790 Smartsite Vented Vial Access Device, Model TBDCardinal Health, Alaris Products · 2005
- Descendant · cites it directly · 1 of its ownK151963 SmartSite Vented Vial Access DeviceYukon Medical, LLC · 2015
- Descendant · cites it directly · 1 of its ownK132863 Smartsite VialshieldYukon Medical, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK243486 SmartSiteTM Vented Vial Access DeviceYukon Medical, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK172884 Arisure Closed Vial AdapterYukon Medical · 2017
- Descendant · cites it directly · 0 of its ownK072511 Swabable Vial Adapter 13MM, Swabable Vial Adapter 20MMMedimop Medical Projects, Ltd. · 2007
Most influential descendants
Showing 5 of 5 · See all- K151963SmartSite Vented Vial Access DeviceYukon Medical, LLC · 2015 · cites it directly1descendant
- K132863Smartsite VialshieldYukon Medical, LLC · 2013 · cites it directly1descendant
- K243486SmartSiteTM Vented Vial Access DeviceYukon Medical, LLC · 2024 · 2 generations on0descendants
- K172884Arisure Closed Vial AdapterYukon Medical · 2017 · 2 generations on0descendants
- K072511Swabable Vial Adapter 13MM, Swabable Vial Adapter 20MMMedimop Medical Projects, Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901063 | Luer Lock Transfer Pin | Acacia, Inc. | 1990 | — |
| −1 | K970485 | Smartsite Access Pin | Ivac Medical Systems | 1997 | 3 |
| 0 (this device) | K052790 | Smartsite Vented Vial Access Device, Model TBD | Cardinal Health, Alaris Products | 2005 | — |
| +1 | K151963 | SmartSite Vented Vial Access Device | Yukon Medical, LLC | 2015 | — |
| +1 | K132863 | Smartsite Vialshield | Yukon Medical, LLC | 2013 | — |
| +2 | K243486 | SmartSiteTM Vented Vial Access Device | Yukon Medical, LLC | 2024 | — |
| +2 | K172884 | Arisure Closed Vial Adapter | Yukon Medical | 2017 | — |
| +1 | K072511 | Swabable Vial Adapter 13MM, Swabable Vial Adapter 20MM | Medimop Medical Projects, Ltd. | 2007 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K983794 | Chemo Mini Spike PlusSummary page 2…redicate devices: Predicate Device Manufacturer 510(k) No. Date Cleared Chemo Dispensing Pin B. Braun K983794 3/23/99 SmartSite® Access Pin Cardinal Health, Alaris K970485 4/21/97… | 1999 |
| * | K970485 | Smartsite Access PinSummary page 2…510(k) No. Date Cleared Chemo Dispensing Pin B. Braun K983794 3/23/99 SmartSite® Access Pin Cardinal Health, Alaris K970485 4/21/97 Products* Originallysubmitted by IVAC Holdings. CardinalHealth, Alaris Pr… | 1997 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K151963 (Yukon Medical, LLC, 2015) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K983794.
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.
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 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/K052790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052790: Smartsite Vented Vial Access Device, Model TBD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052790
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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