510(k) · Cleared
Recalled · Class II · 2016Viapeel Peelable Introducer
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 Nov 9, 2007 as substantially equivalent to K063182 (Enpath Medical, Inc., 2006) after an 88-day review. Its family tree reaches back 5 generations to 1993. It has been recalled once.
- Decided
- Nov 9, 2007
- Review
- 88 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K932323 (1993). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 4 generations backK021004 Valved Peelable IntroducerMedamicus, Inc. · 2002
- 3 generations backK030905 Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2003
- 2 generations backK040150 Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2004
- 1 generation backK063182 Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXXEnpath Medical, Inc. · 2006
- This deviceK072248 Viapeel Peelable IntroducerEnpath Medical, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K932323 | Percutaneous Introducer | Medamicus, Inc. | 1993 | — |
| −4 | K021004 | Valved Peelable Introducer | Medamicus, Inc. | 2002 | — |
| −3 | K030905 | Medamicus Flowguard Peelable Introducer | Medamicus, Inc. | 2003 | — |
| −2 | K040150 | Modification to Medamicus Flowguard Peelable Introducer | Medamicus, Inc. | 2004 | — |
| −1 | K063182 | Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXX | Enpath Medical, Inc. | 2006 | — |
| 0 (this device) | K072248 | Viapeel Peelable Introducer | Enpath Medical, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 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? (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 |
|---|---|---|---|
| * | K063182 | Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXXSummary page 1…ards applicable to this product have been developed under Section 514 of the Act. Predicate Device Enpath Medical, Inc. ViaSeal Valved Peelable Introducer (K063 182) Device Description The ViaPeel Peelable Introducer will be available in 3.5F through 7F (micro), and… | 2006 |
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 |
|---|---|---|---|---|
| Nov 11, 2016 | Class II | Z-2781-2017 | Process control | Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K063182.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 ViaPeelTM Peelable Introducer is intended 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/K072248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072248: Viapeel Peelable Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072248
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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