510(k) · Cleared
ClearedPtfe 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 Oct 29, 2009 as substantially equivalent to K081394 (Enpath Medical, Inc., 2008) after a 30-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Oct 29, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000824 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK000824 Percutaneous Introducer, Model 10383-XXXMedamicus, Inc. · 2000
- 1 generation backK081394 Ptfe Interlock Peelable IntroducersEnpath Medical, Inc. · 2008
- This deviceK093023 Ptfe Peelable IntroducerGreat Batch Medical · 2009
- Descendant · cites it directly · 1 of its ownK102540 Ptfe Portable IntroducerGreat Batch Medical · 2010
- Descendant · 2 generations on · 0 of its ownK123974 Percutaneous Introducer KitTeleflex, Inc. · 2013
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 |
|---|---|---|---|---|---|
| −2 | K000824 | Percutaneous Introducer, Model 10383-XXX | Medamicus, Inc. | 2000 | — |
| −1 | K081394 | Ptfe Interlock Peelable Introducers | Enpath Medical, Inc. | 2008 | — |
| 0 (this device) | K093023 | Ptfe Peelable Introducer | Great Batch Medical | 2009 | — |
| +1 | K102540 | Ptfe Portable Introducer | Great Batch Medical | 2010 | — |
| +2 | K123974 | Percutaneous Introducer Kit | Teleflex, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K081394 | Ptfe Interlock Peelable IntroducersSummary page 1…standards applicable to this product have been developed under Section 514 of the Act. 4.4 Predicate Device Greatbatch Medical PTFE Peelable Introducer (K081394) 4.5 Device Description The Greatbatch Medical PTFE Peelable Introducer kit consists of a disposable needle, a d… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102540 | Ptfe Portable Introducer | 2010 | 1 |
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 9 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K102540 (Great Batch Medical, 2010) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 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/K093023 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093023: Ptfe Peelable Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093023
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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