Cleared Traditional

VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX (K022257) - FDA 510(k) Clearance

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

K022257 · Vomed Volzer Medizintechnik GmbH & Co. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
84d
Days
Class 2
Risk

K022257 is an FDA 510(k) clearance for the VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-90.... Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by Vomed Volzer Medizintechnik GmbH & Co. (Amsterdam, Nh, NL). The FDA issued a Cleared decision on October 4, 2002 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1390 - 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 Vomed Volzer Medizintechnik GmbH & Co. devices

Submission Details

510(k) Number K022257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2002
Decision Date October 04, 2002
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRC Trocar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1390
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 - DRC Trocar

All 50
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K022257.
Accusafe Transseptal Guidewire (GTR31180, GTR31230)
K240246 · Synaptic Medical Corporation · Jul 2024
SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
K241042 · Pressure Products Medical Device Manufacturing, LLC · May 2024
SafeSept® Transseptal Guidewire (SS-140)
K221707 · Pressure Products Medical Device Manufacturing, LLC · Sep 2022
PathBuilder Transseptal Needle
K212625 · Shanghai Microport EP Medtech Co., Ltd. · Mar 2022
SafeSept Blunt Needle
K210328 · Pressure Products Medical Device Manufacturing, LLC · Mar 2021
TSN Transseptal Needle
K172950 · Pressure Products Medical Device Manufacturing, LLC · Feb 2018