510(k) · Cleared
ClearedNAMIC Dilator and Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, LP · DYB Introducer, Catheter
Cleared on Jul 29, 2026 as substantially equivalent to K171275 (Cook Incorporated, 2017) after a 258-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- Jul 29, 2026
- Review
- 258 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K011084 (2001). 15 ancestors in all, the oldest K932323 (1993). No later device cites it as a predicate yet.
- Root · 8 generations backK011084 Mandrel Guidewire AssemblyLake Region Mfg., Inc. · 2001
- 7 generations backK013024 Selectiva GuidewireNeometrics, Inc. · 2001
- 6 generations backK031652 Vascupuncture Picc GuidewireNeometrics, Inc. · 2003
- 5 generations backK040786 Vascupuncture Picc Guidewire with Hydro-Silk CoatingNeometrics, Inc. · 2004
- 4 generations backK043398 Modification to Vascupuncture Picc GuidewireNeometrics, Inc. · 2005
- 3 generations backK112631 Vsi GuidewireVascular Solutions, Inc. · 2011
- 2 generations backK133114 Micropuncture Introducer SetCook Incorporated · 2014
- 1 generation backK171275 Micropuncture Introducer Set, Micropuncture Introducer Set with…Cook Incorporated · 2017
- This deviceK253526 NAMIC Dilator and SheathMedline Industries, LP · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K011084 | Mandrel Guidewire Assembly | Lake Region Mfg., Inc. | 2001 | — |
| −7 | K013024 | Selectiva Guidewire | Neometrics, Inc. | 2001 | — |
| −6 | K031652 | Vascupuncture Picc Guidewire | Neometrics, Inc. | 2003 | — |
| −5 | K040786 | Vascupuncture Picc Guidewire with Hydro-Silk Coating | Neometrics, Inc. | 2004 | — |
| −4 | K043398 | Modification to Vascupuncture Picc Guidewire | Neometrics, Inc. | 2005 | — |
| −3 | K112631 | Vsi Guidewire | Vascular Solutions, Inc. | 2011 | — |
| −2 | K133114 | Micropuncture Introducer Set | Cook Incorporated | 2014 | — |
| −1 | K171275 | Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus… | Cook Incorporated | 2017 | — |
| 0 (this device) | K253526 | NAMIC Dilator and Sheath | Medline Industries, LP | 2026 | — |
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 |
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 |
|---|---|---|---|
| * | K171275 | Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design…Summary page 5…fication Name: Catheter Introducer Product Code: DYB Classification Panel: Cardiovascular Regulatory Class: Class II Regulation Number: 21 CFR 870.1340 Predicate Device K171275 – Cook Micropuncture Introducer Set Device Description The NAMIC Dilator and Sheath are used to gain access to the body for safe… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 15 ancestors have a recall of any class.
- 1 other device also cites its predicate K171275.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 NAMIC Dilator and Sheath are 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 as stated in the FDA summary.
https://510kreport.com/device/K253526 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253526: NAMIC Dilator and Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253526
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026