510(k) · Cleared
ClearedClaveQS™ Bag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icu Medical, Inc. · KPE Container, I.V.
Cleared on Mar 20, 2026 as substantially equivalent to K201936 (Gilero, LLC, 2021) after a 266-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Mar 20, 2026
- Review
- 266 days
- Class
- Class II
- Product code
- KPE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K932477 (1994). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK932477 Unimix Conainer-Empty Container W/3 Lead Trans.SetBaxter Healthcare Corp · 1994
- 5 generations backK983294 All-in-One Container Cat#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102…Baxter Healthcare Corp · 1998
- 4 generations backK041415 Eva TPN ContainerB.Braun Medical, Inc. · 2004 · Recalled
- 3 generations backK101412 Eva TPN BagValmed S.R.L. · 2011
- 2 generations backK181393 Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP…Valmed S.R.L. · 2019
- 1 generation backK201936 SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mLGilero, LLC · 2021
- This deviceK251980 ClaveQS™ BagIcu Medical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K932477 | Unimix Conainer-Empty Container W/3 Lead Trans.Set | Baxter Healthcare Corp | 1994 | — |
| −5 | K983294 | All-in-One Container Cat#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152… | Baxter Healthcare Corp | 1998 | — |
| −4 | K041415 | Eva TPN Container | B.Braun Medical, Inc. | 2004 | 1 |
| −3 | K101412 | Eva TPN Bag | Valmed S.R.L. | 2011 | — |
| −2 | K181393 | Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP… | Valmed S.R.L. | 2019 | — |
| −1 | K201936 | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL | Gilero, LLC | 2021 | — |
| 0 (this device) | K251980 | ClaveQS™ Bag | Icu Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (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 |
|---|---|---|---|
| * | K201936 | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mLSummary page 5…880.5025 Product Code(s) KPE | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K201936 SmartSite Bag KPE Device Description Summary 21 CFR 807.92(a)(4) The ClaveQS™ Bag is an empty EVA container with integral Clave… | 2021 |
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 32 years and passes through 5 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K201936.
How does its category compare?
All KPE devicesKPE Container, I.V.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 ClaveQS™ Bag is intended for compounding and administration of parenteral solutions. Medication transfer in and out of the ClaveQS™ Bag is done using aseptic technique.
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/K251980 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251980: ClaveQS™ Bag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251980
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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