510(k) · Cleared
Recalled · 2010Optiseal Enpath Valved Ptfe Peelable Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Great Batch Medical · DYB Introducer, Catheter
Cleared on Mar 15, 2010 as substantially equivalent to K063182 (Enpath Medical, Inc., 2006) and 1 other predicate after a 152-day review. Its family tree reaches back 5 generations to 1993. It has been recalled once.
- Decided
- Mar 15, 2010
- Review
- 152 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K932323 (1993). 12 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 deviceK093232 Optiseal Enpath Valved Ptfe Peelable IntroducerGreat Batch Medical · 2010
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) | K093232 | Optiseal Enpath Valved Ptfe Peelable Introducer | Great Batch Medical | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K063182 | Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXXSummary page 2…ble Introducer, available in both non-sideport and sideport configurations, is a modification of the previously cleared non-sideport ViaSeal Valved Peelable Introducers (K063182). The OptiSeal Valved PTFE Peelable Introducer configurations covered by this submission are identical in function, mechanism of… | 2006 |
| * | K070159 | Prelude Sheath IntroducerSummary page 2…roducer with sideport shares a similar intended use, with respect to use in the venous system, and mechanism of action as the sideported Merit Prelude Sheath Introducer (K070159). 5.6 Summary of Testing The OptiSeal Valved PTFE Peelable Introducer passed all verification specification criteria for dimens… | 2007 |
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 |
|---|---|---|---|---|
| Jul 2, 2010 | Not classified | Z-2294-2010 | Packaging | The outer sterile barrier (pouch) packaging for the 12 Fr device is not intact. No breaches in the inner sterile barrier (tray/tyvek lid) have been identified. The OptiSeal introducer and accessories sealed in the tray are sterile.… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 6 of the 12 ancestors have 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. 2010, 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 OptiSealTM Valved PTFE 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/K093232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093232: Optiseal Enpath Valved Ptfe 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/K093232
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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