510(k) · Cleared
Recalled · 2011Automix 3+3 Compounder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · LHI Set, I.V. Fluid Transfer
Cleared on Oct 6, 1989 after a 67-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it. It has been recalled once.
- Decided
- Oct 6, 1989
- Review
- 67 days
- Class
- Class II
- Product code
- LHI
- Recalls
- 1
- Predicates
- 0
14 later devices descend from it, 2 citing it directly.
- This deviceK894827 Automix 3+3 CompounderBaxter Healthcare Corp · 1989
- Descendant · cites it directly · 11 of its ownK040456 Fleboset MultipleLaboratorios Grifols, S.A. · 2004
- Descendant · 2 generations on · 6 of its ownK050339 Set Gri-Fill 3.0-1 Way, 2 Ways, MultipleLaboratorios Grifols, S.A. · 2005
- Descendant · 3 generations on · 3 of its ownK152441 KIRO SetKiro Robotics S.L. · 2015
- Descendant · 2 generations on · 2 of its ownK082752 QuickpinLaboratorios Grifols, S.A. · 2008
- Descendant · 3 generations on · 1 of its ownK170110 Diana Medication Transfer SetIcu Medical, Inc. · 2018 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K040456Fleboset MultipleLaboratorios Grifols, S.A. · 2004 · cites it directly11descendants
- K050339Set Gri-Fill 3.0-1 Way, 2 Ways, MultipleLaboratorios Grifols, S.A. · 2005 · 2 generations on6descendants
- K152441KIRO SetKiro Robotics S.L. · 2015 · 3 generations on3descendants
- K082752QuickpinLaboratorios Grifols, S.A. · 2008 · 2 generations on2descendants
- K170110Diana Medication Transfer SetIcu Medical, Inc. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894827 | Automix 3+3 Compounder | Baxter Healthcare Corp | 1989 | — |
| +1 | K040456 | Fleboset Multiple | Laboratorios Grifols, S.A. | 2004 | — |
| +2 | K050339 | Set Gri-Fill 3.0-1 Way, 2 Ways, Multiple | Laboratorios Grifols, S.A. | 2005 | — |
| +3 | K152441 | KIRO Set | Kiro Robotics S.L. | 2015 | — |
| +2 | K082752 | Quickpin | Laboratorios Grifols, S.A. | 2008 | — |
| +3 | K170110 | Diana Medication Transfer Set | Icu Medical, Inc. | 2018 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (14)
See all 142 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 |
|---|---|---|---|---|
| Jan 27, 2011 | Not classified | Z-1385-2011 | Other | The AUTOMIX compounder may not respond correctly to the key pressed by the operator using the keypad. The incorrect keypad response issue can occur both in manual data entry mode (STD Mode) and when entering order numbers to download from… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040456 (Laboratorios Grifols, S.A., 2004) has gone furthest, with 11 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/K894827 · printed Nov 4, 2026
Cite this page
510(k) Report. “K894827: Automix 3+3 Compounder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K894827
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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