510(k) · Cleared
Recalled · Class II · 2013Addease 20MM Binary Connector with 17 GA. Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · LHI Set, I.V. Fluid Transfer
Cleared on Apr 27, 2009 as substantially equivalent to K900865 (Kendall Mcgaw Laboratories, Inc., 1990) after a 26-day review. Its family tree reaches back 1 generation to 1990. 3 later devices descend from it. It has been recalled 4 times.
- Decided
- Apr 27, 2009
- Review
- 26 days
- Class
- Class II
- Product code
- LHI
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K900865 (1990). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK900865 Add-a-Vial II Binary ConnectorKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- This deviceK090905 Addease 20MM Binary Connector with 17 GA. NeedleB.Braun Medical, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK192154 Rio Vial-to-Bag Drug Reconstitution DeviceIcu Medical · 2020
- Descendant · 2 generations on · 0 of its ownK243985 Rio™ Drug Reconstitution Transfer DeviceIcu Medical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK133602 Add-Vantage AddaptorHospira, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900865 | Add-a-Vial II Binary Connector | Kendall Mcgaw Laboratories, Inc. | 1990 | 2 |
| 0 (this device) | K090905 | Addease 20MM Binary Connector with 17 GA. Needle | B.Braun Medical, Inc. | 2009 | — |
| +1 | K192154 | Rio Vial-to-Bag Drug Reconstitution Device | Icu Medical | 2020 | — |
| +2 | K243985 | Rio™ Drug Reconstitution Transfer Device | Icu Medical, Inc. | 2025 | — |
| +1 | K133602 | Add-Vantage Addaptor | Hospira, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K900865 | Add-a-Vial II Binary ConnectorSummary page 1…ON: Product Code LHI CURRENTLY MARKETED DEVICE (PREDICATE): addEASE Binary Connector, 13 and 20 mm (Add-A-Vial II 510(k) K900865) DESCRIPTION: The addEASE 20 mm Binary Connector with 17 Ga. needle is a double ended… | 1990 |
What descends from it? (3)
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… |
| Jun 24, 2010 | Not classified | Z-0305-2011 | Device Design | During this insertion, fragmentation of the PAB container stopper may occur resulting in a small amount of visible particulates in the solution. |
| Jun 24, 2010 | Not classified | Z-0306-2011 | Device Design | During this insertion, fragmentation of the PAB container stopper may occur resulting in a small amount of visible particulates in the solution. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2009, 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 addEASE 20 mm Binary Connector with 17 Ga. Needle is a double ended transfer device intended for use in a pharmacy setting to connect a B. Braun 250mL Excel® IV solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090905: Addease 20MM Binary Connector with 17 GA. Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090905
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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