510(k) · Cleared
ClearedSmartsite Stopcock
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health, Alaris Products · FMG Stopcock, I.V. Set
Cleared on Dec 14, 2007 as substantially equivalent to K060231 (Elcam Medical Acal, 2006) and 1 other predicate after a 207-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Dec 14, 2007
- Review
- 207 days
- Class
- Class II
- Product code
- FMG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K862691 (1986). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK862691 StopcockRam Development · 1986
- 2 generations backK022895 Elcam Stopcocks and ManifoldsMedical Device Consultants, Inc. · 2002 · Recalled
- 1 generation backK060231 Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated…Elcam Medical Acal · 2006 · Recalled
- This deviceK071400 Smartsite StopcockCardinal Health, Alaris Products · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K862691 | Stopcock | Ram Development | 1986 | — |
| −2 | K022895 | Elcam Stopcocks and Manifolds | Medical Device Consultants, Inc. | 2002 | 14 |
| −1 | K060231 | Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated… | Elcam Medical Acal | 2006 | 20 |
| 0 (this device) | K071400 | Smartsite Stopcock | Cardinal Health, Alaris Products | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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? (2)
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 |
|---|---|---|---|
| * | K060231 | Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-StopcockSummary page 2…e devices: Predicate Device Manufacturer 510(k) No. Date Cleared Elcam Closed Swabbable Elcam Medical K060231 04/13/06 Stopcock SmartSite® Needle Free Valve Cardinal Health, Alaris K960280 04/04/… | 2006 |
| * | K960280 | Ivac Needle Free Valve Administration SetsSummary page 2…Closed Swabbable Elcam Medical K060231 04/13/06 Stopcock SmartSite® Needle Free Valve Cardinal Health, Alaris K960280 04/04/96 Products INTENDED USE The SmartSite® Stopcock is indicated for flu… | 1996 |
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 21 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 4 ancestors have a recall of any class.
- 3 other devices also cite its predicate K060231.
How does its category compare?
All FMG devicesFMG Stopcock, I.V. Set: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 SmartSite® Stopcock is indicated for fluid flow, directional control and for providing access port(s) for administration of solutions and blood products. Typical uses include pressure monitoring, intravenous fluid administration and transfusion. The SmartSite® valve port allows the user to access the primary line without the use of a needle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071400: Smartsite Stopcock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071400
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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