510(k) · Cleared
Recalled · 2011Rapido Cut-a-Way Rotating Hemostasis Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corporation · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Cleared on Jul 2, 2003 as substantially equivalent to K854261 (Advanced Cardiovascular Systems, Inc., 1985) after a 30-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 2, 2003
- Review
- 30 days
- Class
- Class II
- Product code
- DTL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K854261 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK854261 Advanced Cardiovascular Systems Hemostatic ValvesAdvanced Cardiovascular Systems, Inc. · 1985 · Recalled
- This deviceK031688 Rapido Cut-a-Way Rotating Hemostasis ValveGuidant Corporation · 2003
- Descendant · cites it directly · 0 of its ownK052459 6248VAL Adjustable ValveMedtronic Vascular · 2006 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K0524596248VAL Adjustable ValveMedtronic Vascular · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854261 | Advanced Cardiovascular Systems Hemostatic Valves | Advanced Cardiovascular Systems, Inc. | 1985 | 2 |
| 0 (this device) | K031688 | Rapido Cut-a-Way Rotating Hemostasis Valve | Guidant Corporation | 2003 | — |
| +1 | K052459 | 6248VAL Adjustable Valve | Medtronic Vascular | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 DTL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K854261 | Advanced Cardiovascular Systems Hemostatic ValvesSummary page 1…ed use features of the modified Rotating Hemostasis Valve is substantially equivalent with regard to these features in their predicate device, Rotating Hemostasis Valve (K854261/12-04-85) Device Description: The RAPIDOTMCut-Away Rotating Hemostasis Valve is recommended for use during vascular procedures i… | 1985 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052459 | 6248VAL Adjustable Valve | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 7, 2011 | Not classified | Z-2793-2011 | Process control | Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for ETO… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DTL devicesDTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTL
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · DTL
36in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTL
1in 2025
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DTL
110in 2025
MAUDE reports naming product code DTL, 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 | 1 | — | 0 | 37 |
| 2008 | 5 | 85 | 1 | 16 |
| 2009 | 2 | — | 0 | 62 |
| 2010 | 4 | 115 | 3 | 148 |
| 2011 | 0 | — | 1 | 160 |
| 2012 | 8 | 36 | 2 | 53 |
| 2013 | 1 | — | 1 (1) | 67 |
| 2014 | 2 | — | 1 | 80 |
| 2015 | 1 | — | 0 | 89 |
| 2016 | 0 | — | 0 | 67 |
| 2017 | 0 | — | 2 | 106 |
| 2018 | 0 | — | 0 | 84 |
| 2019 | 0 | — | 0 | 76 |
| 2020 | 0 | — | 0 | 53 |
| 2021 | 0 | — | 0 | 55 |
| 2022 | 0 | — | 2 | 48 |
| 2023 | 0 | — | 0 | 46 |
| 2024 | 0 | — | 0 | 452 |
| 2025 | 0 | — | 1 | 110 |
| 2026 | 0 | — | 3 (3) | — |
What is it indicated for?
The Rotating Hemostasis Valve is intended for maintaining a fluid-tight seal around devices, including implantable coronary venous leads, during the implant procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031688: Rapido Cut-a-Way Rotating Hemostasis Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031688
Report an extraction error
Are you the manufacturer?
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