510(k) · Cleared
Recalled · Class I · 2026Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxa Corp. · LHI Set, I.V. Fluid Transfer
Cleared on Mar 28, 2001 after a 210-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 6 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled 15 times, including 6 Class I recalls.
- Decided
- Mar 28, 2001
- Review
- 210 days
- Class
- Class II
- Product code
- LHI
- Recalls
- 15 (6 Class I)
- Predicates
- 0
5 later devices descend from it, 5 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- This deviceK002705 Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400Baxa Corp. · 2001
- Descendant · cites it directly · 1 of its ownK022523 Rapid-Fill Tubeset, Model 90005Baxa Corp. · 2002
- Descendant · cites it directly · 0 of its ownK192770 S dispensing lineAea Srl · 2020
- Descendant · cites it directly · 0 of its ownK151423 APEX Compounding System Transfer SetB.Braun Medical, Inc. · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK132011 Apoteca Dug Compounding Dosing Device,Apoteca I.V. Transfer SetAea Srl · 2014
- Descendant · cites it directly · 0 of its ownK041222 Pinnacle TPN Management System Transfer SetB.Braun Medical, Inc. · 2004
Most influential descendants
Showing 5 of 5 · See all- K022523Rapid-Fill Tubeset, Model 90005Baxa Corp. · 2002 · cites it directly1descendant
- K192770S dispensing lineAea Srl · 2020 · cites it directly0descendants
- K151423APEX Compounding System Transfer SetB.Braun Medical, Inc. · 2016 · cites it directly0descendants
- K132011Apoteca Dug Compounding Dosing Device,Apoteca I.V. Transfer SetAea Srl · 2014 · cites it directly0descendants
- K041222Pinnacle TPN Management System Transfer SetB.Braun Medical, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002705 | Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400 | Baxa Corp. | 2001 | — |
| +1 | K022523 | Rapid-Fill Tubeset, Model 90005 | Baxa Corp. | 2002 | — |
| +1 | K192770 | S dispensing line | Aea Srl | 2020 | — |
| +1 | K151423 | APEX Compounding System Transfer Set | B.Braun Medical, Inc. | 2016 | 1 |
| +1 | K132011 | Apoteca Dug Compounding Dosing Device,Apoteca I.V. Transfer Set | Aea Srl | 2014 | — |
| +1 | K041222 | Pinnacle TPN Management System Transfer Set | B.Braun Medical, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 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.
1 device in this family has a Class I recall. 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)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 22, 2026 | Class II | Z-2262-2026 | Under Investigation by firm | Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system alarms. This issue… |
| Aug 20, 2024 | Class I | Z-3085-2024 | Other | Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and… |
| Aug 20, 2024 | Class I | Z-3083-2024 | Other | Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and… |
| Aug 20, 2024 | Class I | Z-3082-2024 | Other | Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and… |
| Aug 20, 2024 | Class I | Z-3084-2024 | Other | Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and… |
| Dec 22, 2023 | Class I | Z-1002-2024 | Device Design | An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill… |
| Dec 22, 2023 | Class I | Z-1001-2024 | Device Design | An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill… |
| Jul 14, 2022 | Class II | Z-1570-2022 | Process control | There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets. |
| Apr 25, 2018 | Class II | Z-1908-2018 | Labeling Change Control | Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the… |
| Apr 25, 2018 | Class II | Z-1910-2018 | Labeling Change Control | Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the… |
| Apr 25, 2018 | Class II | Z-1911-2018 | Labeling Change Control | Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the… |
| Apr 25, 2018 | Class II | Z-1909-2018 | Labeling Change Control | Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the… |
| Jun 4, 2013 | Class II | Z-1752-2013 | Nonconforming Material/Component | Baxter Healthcare is recalling certain ExactaMix automated compounding devices due to the complementary metal oxide semi-conductor battery failure resulting in resetting the internal clock of the device to midnight December 31, 2010. |
| Feb 10, 2010 | Not classified | Z-1197-2010 | Nonconforming Material/Component | Molding defect in the valve body causes leaking. |
| Nov 7, 2003 | Not classified | Z-0210-04 | Other | If device stops due to an alarm or operater pause, inlet valves will remain open, allowing some unwanted mixing of ingredients in the valve chamber.. |
The 5 latest of 15 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K022523 (Baxa Corp., 2002) has gone furthest, with 1 descendant 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/K002705 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002705: Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002705
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026