Cleared Traditional

K022257 - VOMED PERIPHERAL VASCULAR ACCESSORIES

K022257 is an FDA 510(k) clearance for VOMED PERIPHERAL VASCULAR ACCESSORIES, manufactured by Vomed Volzer Medizintechnik GmbH & Co.. The device is a Class 2 Cardiovascular device with product code DRC cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K022257 · Vomed Volzer Medizintechnik GmbH & Co. · Cardiovascular device
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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

FDA 510(k) Submission Details - K022257

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.

DRC Device Classification - Class 2, Special Controls

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 30
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K022257.
SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE
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MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5
K022117 · Merit Medical Systems, Inc. · Oct 2002
MANAN POTTS-COURNAND NEEDLE
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MANAN
K974743 · Medical Device Technologies, Inc. · Apr 1998
MANAN GWI GUIDE WIRE INTRODUCER
K974745 · Medical Device Technologies, Inc. · Apr 1998