510(k) · Cleared
ClearedPinnacle TPN Management System Transfer Set
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 Oct 14, 2004 as substantially equivalent to K002705 (Baxa Corp., 2001) and 1 other predicate after a 157-day review. Its family tree reaches back 2 generations to 1989. 1 of the 4 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 14, 2004
- Review
- 157 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K894827 (1989). 3 ancestors in all. No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK894827 Automix 3+3 CompounderBaxter Healthcare Corp · 1989 · Recalled
- 1 generation backK961008 Automix 3+3/as Compounder SystemBaxter Healthcare Corp · 1997 · Recalled
- This deviceK041222 Pinnacle TPN Management System Transfer SetB.Braun Medical, Inc. · 2004
Class I recalls in this family
- K002705 Exacta-Mix 2400 Compounding System, Model…direct predicate · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894827 | Automix 3+3 Compounder | Baxter Healthcare Corp | 1989 | 1 |
| −1 | K961008 | Automix 3+3/as Compounder System | Baxter Healthcare Corp | 1997 | 1 |
| 0 (this device) | K041222 | Pinnacle TPN Management System Transfer Set | B.Braun Medical, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 1 |
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.
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? (2)
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 |
|---|---|---|---|
| * | K002705 | Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400Summary page 1…Exacta-MixTm 2400 Compounding System Administration Set, K002705 Baxter Healthcare Corporation Autornix(P 3+3/AS Co… | 2001 |
| * | K961008 | Automix 3+3/as Compounder SystemSummary page 1…Autornix(P 3+3/AS Compounder Transfer Set, K961008 DESCRIPTION: The Pinnaclem TPN Management System Transfer Set is ava… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K002705Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400Baxa Corp. · 2001 · Direct predicate · ◆ in the 2001 ancestors bar of FIG. 16 Class I recalls
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 8.0 years on median.
- 3 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K002705.
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 | — |
What is it indicated for?
The Pinnacle Transfer Set is intended to be used with the Pinnacle TPN Management System gravimetric pharmacy compounding device in the pharmacy to provide a sterile fluid path for the compounding of ingredients from multiple source containers into a final container.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041222 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041222: Pinnacle TPN Management System Transfer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041222
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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