Cleared Traditional

K042889 - DYNAMOMETER - MODEL FCE AND MODEL MSC

K042889 is an FDA 510(k) clearance for DYNAMOMETER - MODEL FCE AND MODEL MSC, manufactured by Ametek. The device is a Class 2 Neurology device with product code LBB cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K042889 · Ametek · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
28d
Days
Class 2
Risk

K042889 is an FDA 510(k) clearance for the DYNAMOMETER - MODEL FCE AND MODEL MSC. Classified as Dynamometer, Ac-powered (product code LBB), Class II - Special Controls.

Submitted by Ametek (Largo, US). The FDA issued a Cleared decision on November 16, 2004 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1240 - the FDA neurology 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 Ametek devices

FDA 510(k) Submission Details - K042889

510(k) Number K042889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2004
Decision Date November 16, 2004
Days to Decision 28 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 148d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBB Device Classification - Class 2, Special Controls

Product Code LBB Dynamometer, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1240
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 Neurology devices follow this clearance model.

Regulatory Peers - LBB Dynamometer, Ac-powered

All 8
Devices cleared under the same product code (LBB) and FDA review panel - the closest regulatory comparables to K042889.
DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002
K981730 · Nk Biotechnical Corp. · Jul 1998
ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)
K980363 · Orofacial Dynamics · Apr 1998
MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)
K964933 · Mekanika, Inc. · Feb 1997
DYNAMOMETER
K964685 · John Chatillon & Sons, Inc. · Jan 1997
ELECTRO-GONIOMETER DIAGNOSTIC DEVICE
K901290 · Chattanooga Group, Inc. · Oct 1990
KIN-COM JR
K881388 · Chattanooga Group, Inc. · Apr 1988