510(k) · Cleared
ClearedChartermed TPN-Eva Bags
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chartermed, Inc. · KPE Container, I.V.
Cleared on Nov 24, 1997 as substantially equivalent to K902079 (Chartermed, Inc., 1990) and 1 other predicate after a 97-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Nov 24, 1997
- Review
- 97 days
- Class
- Class II
- Product code
- KPE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K902079 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK902079 Admixture Container for Total Parenteral NutritionChartermed, Inc. · 1990
- This deviceK973103 Chartermed TPN-Eva BagsChartermed, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902079 | Admixture Container for Total Parenteral Nutrition | Chartermed, Inc. | 1990 | — |
| 0 (this device) | K973103 | Chartermed TPN-Eva Bags | Chartermed, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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 |
|---|---|---|---|
| * | K902079 | Admixture Container for Total Parenteral NutritionSummary page 2…tainer made from TOTM plasticized poly vinyl chloride (PVC) under the tradename MIXME. FDA granted substantial equivalency to the MIXME product line in 1990 under 510(k) K902079. Stedim Laboratories of Aubagne, France received notification of substantial equivalency for a comparable device made from ethy… | 1990 |
| * | K911567 | Dual Compartment TPN Bag 3 LiterSummary page 2…aboratories of Aubagne, France received notification of substantial equivalency for a comparable device made from ethylene vinyl acetate (EVA) plastic film under 510(k) K911567. The device is referred to as the "Stedim TPN Bag - Dual E.V.A. empty container for parenteral admixtures designed for use with a… | 1991 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All KPE devicesKPE Container, I.V.: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Empty bags made from ethyl vinyl acetate (EVA) film intended to
contain total parenteral nutrition (TPN) solutions and
compatible medications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973103: Chartermed TPN-Eva Bags.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973103
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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