510(k) · Cleared
ClearedEnpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Enpath Medical, Inc. · DYB Introducer, Catheter
Cleared on Dec 21, 2006 as substantially equivalent to K040150 (Medamicus, Inc., 2004) and 1 other predicate after a 63-day review. Its family tree reaches back 4 generations to 1993. 2 later devices descend from it.
- Decided
- Dec 21, 2006
- Review
- 63 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K932323 (1993). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 3 generations backK021004 Valved Peelable IntroducerMedamicus, Inc. · 2002
- 2 generations backK030905 Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2003
- 1 generation backK040150 Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2004
- This deviceK063182 Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXXEnpath Medical, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK093232 Optiseal Enpath Valved Ptfe Peelable IntroducerGreat Batch Medical · 2010 · Recalled
- Descendant · cites it directly · 0 of its ownK072248 Viapeel Peelable IntroducerEnpath Medical, Inc. · 2007 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932323 | Percutaneous Introducer | Medamicus, Inc. | 1993 | — |
| −3 | K021004 | Valved Peelable Introducer | Medamicus, Inc. | 2002 | — |
| −2 | K030905 | Medamicus Flowguard Peelable Introducer | Medamicus, Inc. | 2003 | — |
| −1 | K040150 | Modification to Medamicus Flowguard Peelable Introducer | Medamicus, Inc. | 2004 | — |
| 0 (this device) | K063182 | Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXX | Enpath Medical, Inc. | 2006 | — |
| +1 | K093232 | Optiseal Enpath Valved Ptfe Peelable Introducer | Great Batch Medical | 2010 | 1 |
| +1 | K072248 | Viapeel Peelable Introducer | Enpath Medical, Inc. | 2007 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 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 DYB? 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 DYB device
- #1 K251051 AuST Steerable Sheathscore 18.0 · 10 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 |
|---|---|---|---|
| * | K040150 | Modification to Medamicus Flowguard Peelable IntroducerSummary page 2…haracteristics of the Enpath ViaSeal Valved Peelable Introducer are substantially equivalent to the predicate device; FlowGuard Valved Peelable Introducer (K040150) including indications for use, operation, manufacturing process, biocompatibility, sterilization method, and packaging.… | 2004 |
| * | K003731 | Safesheath MSP Introducer Sheath Kit with Integral Hemostasis ValveSummary page 2…l Valved Peelable Introducer is also substantially equivalent to the Thomas Medical Products Inc. SafeSheath Introducer Kit with Integral Hemostasis Valve (K003731) with respect to intended use (the introduction of various pacing leads and catheters), device classification (Clas… | 2001 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K093232 (Great Batch Medical, 2010) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K040150.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, 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 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
What is it indicated for?
The Enpath ViaSeal Valved Peelable Introducer is indicated for use in the percutaneous insertion of pacing leads or catheters in the venous system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063182 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063182: Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063182
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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