Cleared Traditional

K991613 - SW ULTRASOUND, MODELS 331, 311, 333

K991613 is an FDA 510(k) clearance for SW ULTRASOUND, manufactured by Starbene. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 578-day FDA review.

K991613 · Starbene · Physical Medicine device
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Dec 2000
Decision
578d
Days
Class 2
Risk

K991613 is an FDA 510(k) clearance for the SW ULTRASOUND, MODELS 331, 311, 333. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Starbene (Cordoba, Pvcia. Cordoba, AR). The FDA issued a Cleared decision on December 8, 2000 after a review of 578 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5300 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Starbene devices

FDA 510(k) Submission Details - K991613

510(k) Number K991613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1999
Decision Date December 08, 2000
Days to Decision 578 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
463d slower than avg
Panel avg: 115d · This submission: 578d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMI Device Classification - Class 2, Special Controls

Product Code IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5300
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 - IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

All 57
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K991613.
MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100
K011955 · Metron Medical Australia, Pty, Ltd. · Jul 2001
ACCUSONIC, MODEL AS-260
K010609 · Metron Medical Australia, Pty, Ltd. · Mar 2001
SONIC MODEL SO-300
K010102 · Metron Medical Australia, Pty, Ltd. · Feb 2001
SONIC, MODEL SO-100
K000593 · Metron Medical Australia, Pty, Ltd. · Aug 2000
ACCUSONIC PLUS, MODEL AP-100
K001370 · Metron Medical Australia, Pty, Ltd. · Jul 2000
EXONIX
K984199 · Fibra Sonics, Inc. · Feb 1999