510(k) · Cleared
ClearedRobertsite Stopcock
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Halkey-Roberts Corp. · FMG Stopcock, I.V. Set
Cleared on May 10, 2006 as substantially equivalent to K955782 (Mednet, Inc., 1996) and 2 other predicates after a 15-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- May 10, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- FMG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K901063 (1990). 10 ancestors in all, the oldest K790472 (1979). No later device cites it as a predicate yet.
- Root · 3 generations backK901063 Luer Lock Transfer PinAcacia, Inc. · 1990
- 2 generations backK970485 Smartsite Access PinIvac Medical Systems · 1997 · Recalled
- 1 generation backK002689 Swabsite Swabbable Valve, Model 245000Quest Medical, Inc. · 2001
- This deviceK061143 Robertsite StopcockHalkey-Roberts Corp. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K901063 | Luer Lock Transfer Pin | Acacia, Inc. | 1990 | — |
| −2 | K970485 | Smartsite Access Pin | Ivac Medical Systems | 1997 | 3 |
| −1 | K002689 | Swabsite Swabbable Valve, Model 245000 | Quest Medical, Inc. | 2001 | — |
| 0 (this device) | K061143 | Robertsite Stopcock | Halkey-Roberts Corp. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K955782 | Med-Net StopcocksSummary page 1…mmon name: IV set stopcock Classification Name: Intravascular Administration Set Accessory Legally Marketed Substantially Equivalent Devices: Med-Net Stopcock (K955782) Robertsite® Needleless Injection Site (K002689) Robertsite® Vial Adapter (K040634) Description of Device: The devi… | 1996 |
| * | K002689 | Swabsite Swabbable Valve, Model 245000Summary page 1…Intravascular Administration Set Accessory Legally Marketed Substantially Equivalent Devices: Med-Net Stopcock (K955782) Robertsite® Needleless Injection Site (K002689) Robertsite® Vial Adapter (K040634) Description of Device: The device is a single use 4-way stopcock with one Robertsit… | 2001 |
| * | K040634 | Robertsite Vial Adapter, Model 245700021Summary page 1…ory Legally Marketed Substantially Equivalent Devices: Med-Net Stopcock (K955782) Robertsite® Needleless Injection Site (K002689) Robertsite® Vial Adapter (K040634) Description of Device: The device is a single use 4-way stopcock with one Robertsite® needleless injection port. The majo… | 2004 |
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 16 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 2 of the 10 ancestors have a recall of any class.
How does its category compare?
All FMG devicesFMG Stopcock, I.V. Set: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Robertsite@ stopcock provides a needleless access port and multi-directional flow during fluid administration to a patient's vascular system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061143 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061143: Robertsite Stopcock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061143
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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