510(k) · Cleared
ClearedMicropuncture Introducer Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · DYB Introducer, Catheter
Cleared on Jul 3, 2014 as substantially equivalent to K101604 (Vascular Solutions, Inc., 2011) and 1 other predicate after a 276-day review. Its family tree reaches back 6 generations to 2001. 4 later devices descend from it.
- Decided
- Jul 3, 2014
- Review
- 276 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K011084 (2001). 13 ancestors in all, the oldest K932323 (1993). 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK011084 Mandrel Guidewire AssemblyLake Region Mfg., Inc. · 2001
- 5 generations backK013024 Selectiva GuidewireNeometrics, Inc. · 2001
- 4 generations backK031652 Vascupuncture Picc GuidewireNeometrics, Inc. · 2003
- 3 generations backK040786 Vascupuncture Picc Guidewire with Hydro-Silk CoatingNeometrics, Inc. · 2004
- 2 generations backK043398 Modification to Vascupuncture Picc GuidewireNeometrics, Inc. · 2005
- 1 generation backK112631 Vsi GuidewireVascular Solutions, Inc. · 2011
- This deviceK133114 Micropuncture Introducer SetCook Incorporated · 2014
- Descendant · cites it directly · 2 of its ownK171275 Micropuncture Introducer Set, Micropuncture Introducer Set with…Cook Incorporated · 2017
- Descendant · 2 generations on · 0 of its ownK253526 NAMIC Dilator and SheathMedline Industries, LP · 2026
- Descendant · 2 generations on · 0 of its ownK240589 Micropuncture Introducer Sets; Micropuncture Pedal Access SetsCook Medical · 2024
- Descendant · cites it directly · 0 of its ownK172980 Micropuncture Pedal Access SetCook Incorporated · 2018
Most influential descendants
Showing 4 of 4 · See all- K171275Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design…Cook Incorporated · 2017 · cites it directly2descendants
- K253526NAMIC Dilator and SheathMedline Industries, LP · 2026 · 2 generations on0descendants
- K240589Micropuncture Introducer Sets; Micropuncture Pedal Access SetsCook Medical · 2024 · 2 generations on0descendants
- K172980Micropuncture Pedal Access SetCook Incorporated · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K011084 | Mandrel Guidewire Assembly | Lake Region Mfg., Inc. | 2001 | — |
| −5 | K013024 | Selectiva Guidewire | Neometrics, Inc. | 2001 | — |
| −4 | K031652 | Vascupuncture Picc Guidewire | Neometrics, Inc. | 2003 | — |
| −3 | K040786 | Vascupuncture Picc Guidewire with Hydro-Silk Coating | Neometrics, Inc. | 2004 | — |
| −2 | K043398 | Modification to Vascupuncture Picc Guidewire | Neometrics, Inc. | 2005 | — |
| −1 | K112631 | Vsi Guidewire | Vascular Solutions, Inc. | 2011 | — |
| 0 (this device) | K133114 | Micropuncture Introducer Set | Cook Incorporated | 2014 | — |
| +1 | K171275 | Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus… | Cook Incorporated | 2017 | — |
| +2 | K253526 | NAMIC Dilator and Sheath | Medline Industries, LP | 2026 | — |
| +2 | K240589 | Micropuncture Introducer Sets; Micropuncture Pedal Access Sets | Cook Medical | 2024 | — |
| +1 | K172980 | Micropuncture Pedal Access Set | Cook Incorporated | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K101604 | Vsi Micro-Introducer Sets (Regular, Stiffen), Models 7197V-7209V, 7240V-7256V, 7259V…Summary page 4…ucer DYB (21 CFR §870.1340) Predicate Devices: The Micropuncture® Introducer Set is substantially equivalent to the VSI Micro-Introducer Set (Vascular Solutions, Inc., K101604) with the VSI Guidewire (K112631). Comparison to Predicate: It has been demonstrated that the Micropunclure'E Introducer Set is… | 2011 |
| * | K112631 | Vsi GuidewireSummary page 4…icate Devices: The Micropuncture® Introducer Set is substantially equivalent to the VSI Micro-Introducer Set (Vascular Solutions, Inc., K101604) with the VSI Guidewire (K112631). Comparison to Predicate: It has been demonstrated that the Micropunclure'E Introducer Set is comparable to the predicate devi… | 2011 |
What descends from it? (4)
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 4 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K171275 (Cook Incorporated, 2017) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K101604.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Micropuncture Introducer Set is intended for the placement of wire guides up to .038 inch diameter into the peripheral vascular system when a small 21 gage needle stick is desired.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K133114 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133114: Micropuncture Introducer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133114
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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