Cleared Traditional

K002058 - VECTORSURGE 5, MODEL VS-500

K002058 is an FDA 510(k) clearance for VECTORSURGE 5, manufactured by Metron Medical Australia, Pty, Ltd.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 327-day FDA review.

K002058 · Metron Medical Australia, Pty, Ltd. · Physical Medicine device
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May 2001
Decision
327d
Days
Class 2
Risk

K002058 is an FDA 510(k) clearance for the VECTORSURGE 5, MODEL VS-500. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Metron Medical Australia, Pty, Ltd. (Carrum Downs, AU). The FDA issued a Cleared decision on May 29, 2001 after a review of 327 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine device 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K002058

510(k) Number K002058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2000
Decision Date May 29, 2001
Days to Decision 327 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
211d slower than avg
Panel avg: 116d · This submission: 327d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 370
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K002058.
NEURO-TRAIN III (3)
K003433 · Sterne Equipment Co., Ltd. · Jun 2001
FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE
K002410 · Dysphagia, LLC · Jun 2001
SMITH & NEPHEW RESTIM
K003596 · Smith & Nephew, Inc. · Jun 2001
TRANSAMERICA DIGITAL EMS
K010665 · Transamerica Medical Systems · Apr 2001
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460
K003260 · Metron Medical Australia, Pty, Ltd. · Feb 2001
RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
K000808 · Rich-Mar Corp. · Aug 2000
K002058 · VECTORSURGE 5, MODEL VS-500
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