Cleared Traditional

K954225 - MED-TEC HAND GRIP

K954225 is an FDA 510(k) clearance for MED-TEC HAND GRIP, manufactured by Medtec, Inc.. The device is a Class 2 Radiology device with product code IXQ cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K954225 · Medtec, Inc. · Radiology device
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Nov 1995
Decision
64d
Days
Class 2
Risk

K954225 is an FDA 510(k) clearance for the MED-TEC HAND GRIP. Classified as Table, Radiographic, Stationary Top (product code IXQ), Class II - Special Controls.

Submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on November 14, 1995 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - the FDA radiology and imaging software 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 Medtec, Inc. devices

FDA 510(k) Submission Details - K954225

510(k) Number K954225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1995
Decision Date November 14, 1995
Days to Decision 64 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXQ Device Classification - Class 2, Special Controls

Product Code IXQ Table, Radiographic, Stationary Top
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
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 Radiology devices follow this clearance model.

Regulatory Peers - IXQ Table, Radiographic, Stationary Top

All 7
Devices cleared under the same product code (IXQ) and FDA review panel - the closest regulatory comparables to K954225.
CARBON FIBER CONFORMAL COUCH TOP
K973842 · Medtec, Inc. · Dec 1997
MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300
K960083 · Wuestec Medical, Inc. · Jul 1996
BUCKY TABLE BK-12
K920729 · Shimadzu Medical Systems · Apr 1992
MILITARY RADIOGRAPHIC FLAT TABLE, CAT # T-9130
K912382 · Continental X-Ray Corp. · Oct 1991
LIEBEL-FLARSHEIM SERIES 8000 BUCKY,W/NON SIZE SENS
K903160 · Continental X-Ray Corp. · Aug 1990
PLURIX C
K781066 · Tecnomed, Inc. · Jul 1978