510(k) · Cleared
ClearedMicro-Stick Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcomp · DYB Introducer, Catheter
Cleared on Jan 8, 2010 as substantially equivalent to K071574 (Enpath Medical, Inc., 2007) and 1 other predicate after a 191-day review. Its family tree reaches back 3 generations to 1993. 3 later devices descend from it.
- Decided
- Jan 8, 2010
- Review
- 191 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K932323 (1993). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 2 generations backK990705 Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific…Medamicus, Inc. · 1999 · Recalled
- 1 generation backK071574 Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. · 2007 · Recalled
- This deviceK091954 Micro-Stick SetMedcomp · 2010
- Descendant · cites it directly · 1 of its ownK130855 Ptfe Super Sheath IntroducerMartech Medical Products · 2013
- Descendant · 2 generations on · 0 of its ownK153246 PTFE Super Sheath Introducer 2.1Medcomp (Medical Components, Inc.) · 2016
- Descendant · cites it directly · 0 of its ownK101399 Coaxial Introducer SetMartech Medical Products · 2010
Most influential descendants
Showing 3 of 3 · See all- K130855Ptfe Super Sheath IntroducerMartech Medical Products · 2013 · cites it directly1descendant
- K153246PTFE Super Sheath Introducer 2.1Medcomp (Medical Components, Inc.) · 2016 · 2 generations on0descendants
- K101399Coaxial Introducer SetMartech Medical Products · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932323 | Percutaneous Introducer | Medamicus, Inc. | 1993 | — |
| −2 | K990705 | Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator… | Medamicus, Inc. | 1999 | 1 |
| −1 | K071574 | Stiffer Coaxial Micro-Introducer Kit | Enpath Medical, Inc. | 2007 | 2 |
| 0 (this device) | K091954 | Micro-Stick Set | Medcomp | 2010 | — |
| +1 | K130855 | Ptfe Super Sheath Introducer | Martech Medical Products | 2013 | — |
| +2 | K153246 | PTFE Super Sheath Introducer 2.1 | Medcomp (Medical Components, Inc.) | 2016 | — |
| +1 | K101399 | Coaxial Introducer Set | Martech Medical Products | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K071574 | Stiffer Coaxial Micro-Introducer KitSummary page 1…assification Name: Catheter Introducer (74 DYB) C.F.R. Section: 880.1340 Class: I C. Predicate Devices: K071574: Enpath Medical Inc, Stiffer Coaxial Micro-Introducer Set K99… | 2007 |
| * | K990705 | Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator SetSummary page 1…C. Predicate Devices: K071574: Enpath Medical Inc, Stiffer Coaxial Micro-Introducer Set K990705: MedAmicus Inc, MedAmicus Coaxial Introducer D. Device Description: The Micro-Stick® S… | 1999 |
What descends from it? (3)
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 17 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K130855 (Martech Medical Products, 2013) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K071574.
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 Micro-Stick® Set is indicated for percutaneous introduction of up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick. The Micro-Stick® Set is not intended for use in the coronary or cerebral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091954 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091954: Micro-Stick Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091954
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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