510(k) · Cleared
Recalled · Class II · 2022HCT Empty EVA Container Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Health Care Technologies · KPE Container, I.V.
Cleared on Aug 15, 2019 as substantially equivalent to K030888 (Metrix Co., 2003) after a 183-day review. Its family tree reaches back 1 generation to 2003. It has been recalled 2 times.
- Decided
- Aug 15, 2019
- Review
- 183 days
- Class
- Class II
- Product code
- KPE
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030888 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK030888 Eva Empty Solution ContainerMetrix Co. · 2003 · Recalled
- This deviceK190328 HCT Empty EVA Container PackHealth Care Technologies · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030888 | Eva Empty Solution Container | Metrix Co. | 2003 | 17 |
| 0 (this device) | K190328 | HCT Empty EVA Container Pack | Health Care Technologies | 2019 | — |
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? (1)
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 |
|---|---|---|---|
| * | K030888 | Eva Empty Solution ContainerSummary page 4…: I.V. Container Panel: General Hospital Product Code: KPE Predicate Device: EVA Empty Solution Container (K030888) Predicate Product Code: KPE (21 CFR 880.5025) Device Description: The subject device is an empty two-port style EVA conta… | 2003 |
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 |
|---|---|---|---|---|
| Dec 15, 2022 | Class II | Z-0937-2023 | Process control | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. |
| Dec 15, 2022 | Class II | Z-0936-2023 | Process control | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K030888.
How does its category compare?
All KPE devicesKPE Container, I.V.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
An empty container with sterile fluid path used to hold an admixture of compatible fluids for administration to a patient. Medication transfer is done using aseptic technique.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190328 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190328: HCT Empty EVA Container Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190328
Report an extraction error
Are you the manufacturer?
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