510(k) · Cleared
Recalled · Class II · 2013Add-a-Vial II Binary Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kendall Mcgaw Laboratories, Inc. · LHI Set, I.V. Fluid Transfer
Cleared on Jul 11, 1990 after a 138-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 11, 1990
- Review
- 138 days
- Class
- Class II
- Product code
- LHI
- Recalls
- 2
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK900865 Add-a-Vial II Binary ConnectorKendall Mcgaw Laboratories, Inc. · 1990
- Descendant · cites it directly · 3 of its ownK090905 Addease 20MM Binary Connector with 17 GA. NeedleB.Braun Medical, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 1 of its ownK192154 Rio Vial-to-Bag Drug Reconstitution DeviceIcu Medical · 2020
- Descendant · 3 generations on · 0 of its ownK243985 Rio™ Drug Reconstitution Transfer DeviceIcu Medical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK133602 Add-Vantage AddaptorHospira, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK973593 Bridge Sentry Bedside Unit, Bridge Sentry Administration…Bridge Medical, Inc. · 1998
Most influential descendants
Showing 5 of 5 · See all- K090905Addease 20MM Binary Connector with 17 GA. NeedleB.Braun Medical, Inc. · 2009 · cites it directly3descendants
- K192154Rio Vial-to-Bag Drug Reconstitution DeviceIcu Medical · 2020 · 2 generations on1descendant
- K243985Rio™ Drug Reconstitution Transfer DeviceIcu Medical, Inc. · 2025 · 3 generations on0descendants
- K133602Add-Vantage AddaptorHospira, Inc. · 2014 · 2 generations on0descendants
- K973593Bridge Sentry Bedside Unit, Bridge Sentry Administration Set-Standard Configuration…Bridge Medical, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900865 | Add-a-Vial II Binary Connector | Kendall Mcgaw Laboratories, Inc. | 1990 | — |
| +1 | K090905 | Addease 20MM Binary Connector with 17 GA. Needle | B.Braun Medical, Inc. | 2009 | 4 |
| +2 | K192154 | Rio Vial-to-Bag Drug Reconstitution Device | Icu Medical | 2020 | — |
| +3 | K243985 | Rio™ Drug Reconstitution Transfer Device | Icu Medical, Inc. | 2025 | — |
| +2 | K133602 | Add-Vantage Addaptor | Hospira, Inc. | 2014 | — |
| +1 | K973593 | Bridge Sentry Bedside Unit, Bridge Sentry Administration Set-Standard… | Bridge Medical, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 4, 2013 | Class II | Z-0424-2014 | Equipment maintenance | Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Based on extensive root cause investigation, it has been determined that the leakage is the result of a… |
| Apr 4, 2013 | Class II | Z-0425-2014 | Equipment maintenance | Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Based on extensive root cause investigation, it has been determined that the leakage is the result of a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K090905 (B.Braun Medical, Inc., 2009) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/K900865 · printed Nov 6, 2026
Cite this page
510(k) Report. “K900865: Add-a-Vial II Binary Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900865
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026