Cleared Traditional

K232662 - BNLE Hydrophilic Jacketed Peripheral Gu...

K232662 is an FDA 510(k) clearance for BNLE Hydrophilic Jacketed Peripheral Gu..., manufactured by Biomerics Nle. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K232662 · Biomerics Nle · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
257d
Days
Class 2
Risk

K232662 is an FDA 510(k) clearance for the BNLE Hydrophilic Jacketed Peripheral Guidewire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Biomerics Nle (Brooklyn Park, US). The FDA issued a Cleared decision on May 14, 2024 after a review of 257 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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. Standard predicate reliance. 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 Biomerics Nle devices

FDA 510(k) Submission Details - K232662

510(k) Number K232662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2023
Decision Date May 14, 2024
Days to Decision 257 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
132d slower than avg
Panel avg: 125d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 545
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K232662.
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