Cleared Traditional

K992545 - TM-300 TRACTION SYSTEM

K992545 is an FDA 510(k) clearance for TM-300 TRACTION SYSTEM, manufactured by Ito Co., Ltd.. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K992545 · Ito Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
33d
Days
Class 2
Risk

K992545 is an FDA 510(k) clearance for the TM-300 TRACTION SYSTEM. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Ito Co., Ltd. (Rockville, US). The FDA issued a Cleared decision on September 1, 1999 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5900 - 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 Ito Co., Ltd. devices

FDA 510(k) Submission Details - K992545

510(k) Number K992545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1999
Decision Date September 01, 1999
Days to Decision 33 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
83d faster than avg
Panel avg: 116d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITH Device Classification - Class 2, Special Controls

Product Code ITH Equipment, Traction, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5900
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 - ITH Equipment, Traction, Powered

All 47
Devices cleared under the same product code (ITH) and FDA review panel - the closest regulatory comparables to K992545.
DYNATRON 900
K993919 · Dynatronics Corp. · Jan 2000
HANG UPS POWER II
K991835 · Stl Intl., Inc. · Dec 1999
AKRON ATP9 TRACTION MACHINE
K992733 · Huntleigh Technology, Inc. · Nov 1999
CTD MARK I TRACTION DEVICE
K991931 · Therasys, Inc. · Aug 1999
DRS SYSTEM
K981822 · Professional Distribution Systems, Inc. · Jun 1998
VAX-D THERAPEUTIC TABLE
K951622 · Vat-Tech, Inc. · Jul 1996