510(k) · Cleared
ClearedDual Chamber TPN Container
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · KPE Container, I.V.
Cleared on Mar 12, 2008 as substantially equivalent to K041415 (B.Braun Medical, Inc., 2004) and 1 other predicate after an 86-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Mar 12, 2008
- Review
- 86 days
- Class
- Class II
- Product code
- KPE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K932477 (1994). 9 ancestors in all, the oldest K911567 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK932477 Unimix Conainer-Empty Container W/3 Lead Trans.SetBaxter Healthcare Corp · 1994
- 2 generations backK983294 All-in-One Container Cat#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102…Baxter Healthcare Corp · 1998
- 1 generation backK041415 Eva TPN ContainerB.Braun Medical, Inc. · 2004 · Recalled
- This deviceK073538 Dual Chamber TPN ContainerB.Braun Medical, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932477 | Unimix Conainer-Empty Container W/3 Lead Trans.Set | Baxter Healthcare Corp | 1994 | — |
| −2 | K983294 | All-in-One Container Cat#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152… | Baxter Healthcare Corp | 1998 | — |
| −1 | K041415 | Eva TPN Container | B.Braun Medical, Inc. | 2004 | 1 |
| 0 (this device) | K073538 | Dual Chamber TPN Container | B.Braun Medical, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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 KPE? 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 KPE device
- #1 K223674 eZSURE™ Empty Fluid Container (models 426030…score 13.1 · 5 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 |
|---|---|---|---|
| * | K041415 | Eva TPN ContainerSummary page 1…TPN Bag DEVICE CLASSIFICATION: I.V. Container Class II, CFR Title 21 § 880.5025 PREDICATE DEVICE: B. Braun EVA TPN Container (K041415) Churchill Medical Dual Chamber Empty Container (K041038) DESCRIPTION: The Dual Chamber TPN (Tota… | 2004 |
| * | K041038 | Churchill Medical Dual Chamber Empty ContainerSummary page 1…Class II, CFR Title 21 § 880.5025 PREDICATE DEVICE: B. Braun EVA TPN Container (K041415) Churchill Medical Dual Chamber Empty Container (K041038) DESCRIPTION: The Dual Chamber TPN (Total Parenteral Nutrition) Container is an empty, sterile ph… | 2004 |
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 14 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K041415.
How does its category compare?
All KPE devicesKPE Container, I.V.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KPE
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPE
183in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPE
16in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · KPE
220in 2025
MAUDE reports naming product code KPE, 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 | 0 | — | 0 | 43 |
| 2008 | 1 | — | 0 | 22 |
| 2009 | 1 | — | 3 | 38 |
| 2010 | 0 | — | 14 | 87 |
| 2011 | 2 | — | 0 | 797 |
| 2012 | 1 | — | 0 | 1,229 |
| 2013 | 1 | — | 0 | 622 |
| 2014 | 0 | — | 2 (2) | 575 |
| 2015 | 0 | — | 0 | 543 |
| 2016 | 0 | — | 0 | 527 |
| 2017 | 0 | — | 1 | 284 |
| 2018 | 0 | — | 13 | 142 |
| 2019 | 3 | 183 | 0 | 205 |
| 2020 | 1 | — | 0 | 147 |
| 2021 | 2 | — | 0 | 162 |
| 2022 | 0 | — | 2 | 112 |
| 2023 | 2 | — | 0 | 127 |
| 2024 | 1 | — | 16 | 158 |
| 2025 | 2 | — | 0 | 220 |
| 2026 | 3 | 270 | 0 | — |
What is it indicated for?
The Dual Chamber TPN Container is intended for use in the compounding and storage of
parenteral nutrition solutions prior to and during administration to a patient using an
intravascular administration set. The Dual Chamber TPN Container can be filled either by
gravity or in conjunction with automated compounding equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073538 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073538: Dual Chamber TPN Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073538
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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