510(k) · Cleared
Recalled · 20086248VAL Adjustable Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Cleared on Jan 11, 2006 as substantially equivalent to K012083 (Medtronic Vascular, 2001) and 3 other predicates after a 126-day review. Its family tree reaches back 3 generations to 1977. It has been recalled once.
- Decided
- Jan 11, 2006
- Review
- 126 days
- Class
- Class II
- Product code
- DTL
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 3 generations to K770977 (1977). 33 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK770977 Cardiovascular Spring GuidesLake Region Mfg., Inc. · 1977 · Recalled
- 2 generations backK963320 TFX Medical GuidewireTfx Medical Group · 1996
- 1 generation backK012083 Attain Access 6218 Left-Heart Delivery System, Model 6218Medtronic Vascular · 2001
- This deviceK052459 6248VAL Adjustable ValveMedtronic Vascular · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K770977 | Cardiovascular Spring Guides | Lake Region Mfg., Inc. | 1977 | 1 |
| −2 | K963320 | TFX Medical Guidewire | Tfx Medical Group | 1996 | — |
| −1 | K012083 | Attain Access 6218 Left-Heart Delivery System, Model 6218 | Medtronic Vascular | 2001 | — |
| 0 (this device) | K052459 | 6248VAL Adjustable Valve | Medtronic Vascular | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 3 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 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? (4)
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 |
|---|---|---|---|
| * | K012083 | Attain Access 6218 Left-Heart Delivery System, Model 6218Summary page 1…ially equivalent with regard to these features, to the following predicate devices: * Medtronic Adjustable 1-emostasis Valve (model]6218VAL)-K012083 and K012130 cleared August 28, 2001. * Guidant Rapido CutbA-Way Rotating Hernostasis Valve - K03… | 2001 |
| * | K012130 | Attain LDS 6216 Left-Heart Delivery SystemSummary page 1…lent with regard to these features, to the following predicate devices: * Medtronic Adjustable 1-emostasis Valve (model]6218VAL)-K012083 and K012130 cleared August 28, 2001. * Guidant Rapido CutbA-Way Rotating Hernostasis Valve - K03 1688 cleare… | 2001 |
| * | K031688 | Rapido Cut-a-Way Rotating Hemostasis ValveSummary page 1…e 1-emostasis Valve (model]6218VAL)-K012083 and K012130 cleared August 28, 2001. * Guidant Rapido CutbA-Way Rotating Hernostasis Valve - K03 1688 cleared July 2, 2003 * Angeion Y-Adaptor with Touhy-Borst Valve - K895580 cleared April 30, 1990… | 2003 |
| * | K895580 | Y-Adapter W/Thouy BorstSummary page 1…* Guidant Rapido CutbA-Way Rotating Hernostasis Valve - K03 1688 cleared July 2, 2003 * Angeion Y-Adaptor with Touhy-Borst Valve - K895580 cleared April 30, 1990 * DMeChIfturIC Confidential Traditional 510(k)… | 1990 |
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 |
|---|---|---|---|---|
| Aug 27, 2008 | Not classified | Z-2471-2008 | Process control | Medtronic has identified an issue with the packaging for specific lots of the Medtronic Adjustable Valve and valves contained in the Attain Left Heart Delivery System kits. A small number of valve package seals could be compromised. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 7 of the 33 ancestors have a recall of any class.
- 6 other devices also cite its predicate K012083.
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 Medtronic model 6248VAL adjustable valve is intended to minimize blood loss during percutaneous catheter procedures used to place cardiac leads and implant accessories such as guide wires and subselecting catheters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052459: 6248VAL Adjustable Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052459
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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