Cleared Traditional

K250305 - Reprocessed Agilis NxT Steerable Introducer (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250305 · Innovative Health · Cardiovascular device
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Jan 2026
Decision
338d
Days
Class 2
Risk

K250305 is an FDA 510(k) clearance for the Reprocessed Agilis NxT Steerable Introducer. Classified as Reprocessed Catheter Introducer (product code PNE), Class II - Special Controls.

Submitted by Innovative Health (Scottsdale, US). The FDA issued a Cleared decision on January 7, 2026 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Innovative Health devices

Submission Details

510(k) Number K250305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2025
Decision Date January 07, 2026
Days to Decision 338 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 125d · This submission: 338d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PNE Reprocessed Catheter Introducer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
Definition Introduce Various Cardiovascular Catheters Into The Heart And Cardiovascular System
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 - PNE Reprocessed Catheter Introducer

Devices cleared under the same product code (PNE) and FDA review panel - the closest regulatory comparables to K250305.
Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer
K250314 · Surgical Instrument Service and Savings, Inc. · Dec 2025
Reprocessed VersaCross Steerable Sheath
K232037 · Innovative Health, LLC · Apr 2024
Reprocessed Agilis NxT Steerable Introducer
K230376 · Innovative Health, LLC · Aug 2023
Reprocessed Carto Vizigo Bi-Directional Guiding Sheath
K212165 · Innovative Health, LLC · Mar 2022