510(k) · Cleared
ClearedMedamicus Flowguard Peelable Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medamicus, Inc. · DYB Introducer, Catheter
Cleared on Apr 9, 2003 as substantially equivalent to K021004 (Medamicus, Inc., 2002) after a 16-day review. Its family tree reaches back 2 generations to 1993. 20 later devices descend from it.
- Decided
- Apr 9, 2003
- Review
- 16 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932323 (1993). 3 ancestors in all. 20 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 1 generation backK021004 Valved Peelable IntroducerMedamicus, Inc. · 2002
- This deviceK030905 Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2003
- Descendant · cites it directly · 19 of its ownK040150 Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2004
- Descendant · 2 generations on · 12 of its ownK090394 Valved Tearway IntroducerMedcomp · 2009
- Descendant · 2 generations on · 4 of its ownK122422 Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx…Care Fusion · 2012
- Descendant · 3 generations on · 2 of its ownK160437 PleurX Peritoneal Catheter SystemCare Fusion · 2016
- Descendant · 3 generations on · 2 of its ownK120617 Ptfe Super Sheath IntroducerMartech Medical Products · 2012
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K040150Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2004 · cites it directly19descendants
- K090394Valved Tearway IntroducerMedcomp · 2009 · 2 generations on12descendants
- K122422Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable…Care Fusion · 2012 · 2 generations on4descendants
- K160437PleurX Peritoneal Catheter SystemCare Fusion · 2016 · 3 generations on2descendants
- K120617Ptfe Super Sheath IntroducerMartech Medical Products · 2012 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932323 | Percutaneous Introducer | Medamicus, Inc. | 1993 | — |
| −1 | K021004 | Valved Peelable Introducer | Medamicus, Inc. | 2002 | — |
| 0 (this device) | K030905 | Medamicus Flowguard Peelable Introducer | Medamicus, Inc. | 2003 | — |
| +1 | K040150 | Modification to Medamicus Flowguard Peelable Introducer | Medamicus, Inc. | 2004 | — |
| +2 | K090394 | Valved Tearway Introducer | Medcomp | 2009 | — |
| +2 | K122422 | Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved… | Care Fusion | 2012 | — |
| +3 | K160437 | PleurX Peritoneal Catheter System | Care Fusion | 2016 | — |
| +3 | K120617 | Ptfe Super Sheath Introducer | Martech Medical Products | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K021004 | Valved Peelable Introducer | 2002 |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040150 | Modification to Medamicus Flowguard Peelable Introducer | 2004 | 19 |
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 10 years and passes through 1 company; a new generation was cleared every 8.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K040150 (Medamicus, Inc., 2004) has gone furthest, with 19 descendants 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.
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 MedAmicus FlowGuardTMPeelable Introducer 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/K030905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030905: Medamicus Flowguard 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/K030905
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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