510(k) · Cleared
Recalled · Class II · 2017Empty Solution Transfer Container 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymer Technology Corp. · KPE Container, I.V.
Cleared on Oct 16, 1984 after a 39-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 2 times.
- Decided
- Oct 16, 1984
- Review
- 39 days
- Class
- Class II
- Product code
- KPE
- Recalls
- 2
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 13, 2017 | Class II | Z-3240-2017 | Error in labeling | The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are correctly made with PVC material, as ordered and as labeled on the inner and outer boxes. |
| Jun 23, 2016 | Class II | Z-2261-2016 | Device Design | An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the… |
No ancestor or descendant has a Class I 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 | — |
https://510kreport.com/device/K843523 · printed Nov 5, 2026
Cite this page
510(k) Report. “K843523: Empty Solution Transfer Container 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K843523
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026