Cleared Traditional

K261529 - Micropuncture Kit / Micropuncture Acces...

Also marketed or referenced as:
Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01) Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)

K261529 is an FDA 510(k) clearance for Micropuncture Kit / Micropuncture Acces..., manufactured by Hartman Medical Group, LLC. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K261529 · Hartman Medical Group, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
59d
Days
Class 2
Risk

K261529 is an FDA 510(k) clearance for the Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ .... Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Hartman Medical Group, LLC (Birmingham, US). The FDA issued a Cleared decision on July 6, 2026 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hartman Medical Group, LLC devices

FDA 510(k) Submission Details - K261529

510(k) Number K261529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2026
Decision Date July 06, 2026
Days to Decision 59 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 125d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 439
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K261529.
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