Cleared Traditional

AMERICAN BANTEX, MODEL MS 3 (K042104) - FDA 510(k) Clearance

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

K042104 · American Bantex Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
78d
Days
Class 2
Risk

K042104 is an FDA 510(k) clearance for the AMERICAN BANTEX, MODEL MS 3. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by American Bantex Corp. (Bountiful, US). The FDA issued a Cleared decision on October 21, 2004 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3800 - 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: 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 American Bantex Corp. devices

Submission Details

510(k) Number K042104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2004
Decision Date October 21, 2004
Days to Decision 78 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 115d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code INI Vehicle, Motorized 3-wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3800
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 - INI Vehicle, Motorized 3-wheeled

All 80
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K042104.
HEARTWAY Power Mobility Scooter
K151656 · Heartway Medical Products Co., Ltd. · Nov 2015
HEARTWAY Power Mobility Scooter
K150998 · Heartway Medical Products Co., Ltd. · Sep 2015
HEARTWAY Power Mobility Scooter, BRIO S19
K150987 · Heartway Medical Products Co., Ltd. · Sep 2015
MEDLINE STRIDER MIDI 4
K042764 · Medline Industries, Inc. · Oct 2004
MODIFICATION TO MEDLINE STRIDER MIDI 3
K042763 · Medline Industries, Inc. · Oct 2004
MEDLINE STRIDER MICRO 3
K041053 · Medline Industries, Inc. · May 2004