510(k) · Cleared
Recalled · Class II · 2020Clave Stopcock
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icu Medical, Inc. · FMG Stopcock, I.V. Set
Cleared on Feb 13, 2008 as substantially equivalent to K941190 (Icu Medical, Inc., 1995) and 2 other predicates after a 33-day review. Its family tree reaches back 1 generation to 1995. It has been recalled 4 times.
- Decided
- Feb 13, 2008
- Review
- 33 days
- Class
- Class II
- Product code
- FMG
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 1 generation to K941190 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK941190 Clave Needle-Less Connector Open Extension SetIcu Medical, Inc. · 1995 · Recalled
- This deviceK080077 Clave StopcockIcu Medical, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941190 | Clave Needle-Less Connector Open Extension Set | Icu Medical, Inc. | 1995 | 1 |
| 0 (this device) | K080077 | Clave Stopcock | Icu Medical, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 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 FMG? 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 FMG device
- #1 K242255 Qitexio® 4-Way Stopcock (QIT014)score 10.5 · 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? (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 |
|---|---|---|---|
| * | K941190 | Clave Needle-Less Connector Open Extension SetSummary page 1…21 CFR 880.5440, Class II Device Product Code: Primary Code: FMG, Secondary Code: LHI Legally Marketed Predicate Devices for Substantial Equivalence: *K941190 - Clave Connector - ICU Medical, Inc. *K970855 - Clave Connector - ICU Medical, Inc. *K953573 - ICU Stopcock with Extension Tubin… | 1995 |
| * | K970855 | Clave ConnectorSummary page 1…Primary Code: FMG, Secondary Code: LHI Legally Marketed Predicate Devices for Substantial Equivalence: *K941190 - Clave Connector - ICU Medical, Inc. *K970855 - Clave Connector - ICU Medical, Inc. *K953573 - ICU Stopcock with Extension Tubing - ICU Medical, Inc. Rationale for SE: This… | 1997 |
| * | K953573 | Icu Stopcok with Extension TubingSummary page 1…de: LHI Legally Marketed Predicate Devices for Substantial Equivalence: *K941190 - Clave Connector - ICU Medical, Inc. *K970855 - Clave Connector - ICU Medical, Inc. *K953573 - ICU Stopcock with Extension Tubing - ICU Medical, Inc. Rationale for SE: This submission is a combination of two devices that… | 1995 |
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 |
|---|---|---|---|---|
| Jul 6, 2020 | Class II | Z-0212-2021 | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. |
| Jul 6, 2020 | Class II | Z-0213-2021 | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. |
| Jul 6, 2020 | Class II | Z-0250-2021 | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. |
| Jul 6, 2020 | Class II | Z-0220-2021 | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 3 ancestors have a recall of any class.
- 3 other devices also cite its predicate K941190.
How does its category compare?
All FMG devicesFMG Stopcock, I.V. Set: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FMG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMG
Too few FMG 510(k)s in any year since 2007 to give a median.
Recalls per year · FMG
33in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMG
868in 2025
MAUDE reports naming product code FMG, 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 | 2 | — | 5 | 26 |
| 2008 | 2 | — | 4 | 48 |
| 2009 | 2 | — | 0 | 27 |
| 2010 | 0 | — | 2 | 131 |
| 2011 | 0 | — | 8 | 95 |
| 2012 | 0 | — | 0 | 93 |
| 2013 | 2 | — | 0 | 117 |
| 2014 | 1 | — | 0 | 105 |
| 2015 | 0 | — | 0 | 96 |
| 2016 | 0 | — | 1 | 148 |
| 2017 | 0 | — | 2 | 114 |
| 2018 | 1 | — | 3 | 164 |
| 2019 | 2 | — | 0 | 400 |
| 2020 | 0 | — | 5 | 284 |
| 2021 | 0 | — | 0 | 245 |
| 2022 | 2 | — | 0 | 280 |
| 2023 | 2 | — | 0 | 689 |
| 2024 | 0 | — | 0 | 935 |
| 2025 | 1 | — | 33 (1) | 868 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that
flow from a container to a patient's vascular system through a needle or catheter
inserted into a vein or artery. This device is a four-way stopcock with an integral
CLAVE side-port for closed, needleless access to the patient tubing or other fluid
container.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080077 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080077: Clave Stopcock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080077
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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