510(k) · Cleared
ClearedAntimicrobial Clave, Models AG Clave, AG Microclave
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icu Medical, Inc. · FPA Set, Administration, Intravascular
Cleared on Apr 10, 2009 as substantially equivalent to K970855 (Icu Medical, Inc., 1997) and 2 other predicates after a 74-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Apr 10, 2009
- Review
- 74 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K915571 (1992). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK915571 Clave ConnectorIcu Medical, Inc. · 1992 · Recalled
- 3 generations backK973916 NP Medical Capless Luer Activated ValveNp Medical, Inc. · 1998
- 2 generations backK072576 Clearlink Antimicrobial Luer Activated Device (Lad) and Extension…Baxter Healthcare Corp · 2007
- 1 generation backK081289 V-Link Antimicrobial Luer Activated Device and Extension Sets with…Baxter Healthcare Corp · 2008
- This deviceK090189 Antimicrobial Clave, Models AG Clave, AG MicroclaveIcu Medical, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915571 | Clave Connector | Icu Medical, Inc. | 1992 | 3 |
| −3 | K973916 | NP Medical Capless Luer Activated Valve | Np Medical, Inc. | 1998 | — |
| −2 | K072576 | Clearlink Antimicrobial Luer Activated Device (Lad) and Extension Sets with… | Baxter Healthcare Corp | 2007 | — |
| −1 | K081289 | V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link… | Baxter Healthcare Corp | 2008 | — |
| 0 (this device) | K090189 | Antimicrobial Clave, Models AG Clave, AG Microclave | Icu Medical, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 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 FPA? 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K970855 | Clave ConnectorSummary page 1…osed Access Classification Name: 21 CFR 880.5440, Class 11 Device, 80FPA and 8OLHI, Accessory Legally Marketed Predicate Devices for Substantial Equivalence: *K970855 - CLAVE Connector - ICU Medical Inc. *K072576 & K081289 - V-LinkTm Antimicrobial Luer Activated Device - Baxter H-ealthcare Corp… | 1997 |
| * | K072576 | Clearlink Antimicrobial Luer Activated Device (Lad) and Extension Sets with the…Summary page 1…FR 880.5440, Class 11 Device, 80FPA and 8OLHI, Accessory Legally Marketed Predicate Devices for Substantial Equivalence: *K970855 - CLAVE Connector - ICU Medical Inc. *K072576 & K081289 - V-LinkTm Antimicrobial Luer Activated Device - Baxter H-ealthcare Corp Rationale for SE: The ICU Medical Antimicrobi… | 2007 |
| * | K081289 | V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial…Summary page 1…0, Class 11 Device, 80FPA and 8OLHI, Accessory Legally Marketed Predicate Devices for Substantial Equivalence: *K970855 - CLAVE Connector - ICU Medical Inc. *K072576 & K081289 - V-LinkTm Antimicrobial Luer Activated Device - Baxter H-ealthcare Corp Rationale for SE: The ICU Medical Antimicrobial CLAVE i… | 2008 |
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 17 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 4 of the 7 ancestors have a recall of any class.
- 14 other devices also cite its predicate K970855.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The Antimicrobial CLAVE® Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to an intravascular administration set for the administration of fluids to a patient through a cannulae placed in the vein or artery.
The connector includes two antimicrobial agents. The first agent is compounded with liquid silicone rubber to provide a protective seal around the cannula. The second, agent is compounded with the polycarbonate alloy and is intended to reduce microbial contamination in the device fluid path. The antimicrobial agents are not intended for treating existing patient infections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090189 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090189: Antimicrobial Clave, Models AG Clave, AG Microclave.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090189
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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