510(k) · Cleared
ClearedRio™ Drug Reconstitution Transfer Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icu Medical, Inc. · LHI Set, I.V. Fluid Transfer
Cleared on Jan 22, 2025 as substantially equivalent to K192154 (Icu Medical, 2020) after a 30-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Jan 22, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K900865 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK900865 Add-a-Vial II Binary ConnectorKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 2 generations backK090905 Addease 20MM Binary Connector with 17 GA. NeedleB.Braun Medical, Inc. · 2009 · Recalled
- 1 generation backK192154 Rio Vial-to-Bag Drug Reconstitution DeviceIcu Medical · 2020
- This deviceK243985 Rio™ Drug Reconstitution Transfer DeviceIcu Medical, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900865 | Add-a-Vial II Binary Connector | Kendall Mcgaw Laboratories, Inc. | 1990 | 2 |
| −2 | K090905 | Addease 20MM Binary Connector with 17 GA. Needle | B.Braun Medical, Inc. | 2009 | 4 |
| −1 | K192154 | Rio Vial-to-Bag Drug Reconstitution Device | Icu Medical | 2020 | — |
| 0 (this device) | K243985 | Rio™ Drug Reconstitution Transfer Device | Icu Medical, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K192154 | Rio Vial-to-Bag Drug Reconstitution DeviceSummary page 5…R 880.5440 Regulation Name Intravascular Administration Set Review Panel General Hospital Product Code(s) LHI Predicate Device K192154, Rio™ Vial-to-Bag Drug Reconstitution Device (ICU Medical Inc.) Predicate Device - Intravascular Administration Set Reg… | 2020 |
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 35 years and passes through 4 companies; a new generation was cleared every 11.0 years on median.
- 2 of the 3 ancestors have 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. 2025, 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?
Rio™ Drug Reconstitution Transfer Device is indicated for single-use reconstituting or mixing of liquid or lyophilized drug in a vial, and the aseptic transfer of the reconstituted drug into the multi-port LifeCare IV container system (IV bag) for patient infusion administration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243985 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243985: Rio™ Drug Reconstitution Transfer Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243985
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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