Cleared Traditional

K931321 - CSD 200/300/400/500 DYNAMOMETER

K931321 is an FDA 510(k) clearance for CSD 200/300/400/500 DYNAMOMETER, manufactured by John Chatillon & Sons, Inc.. The device is a Class 2 Neurology device with product code LBB cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K931321 · John Chatillon & Sons, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
336d
Days
Class 2
Risk

K931321 is an FDA 510(k) clearance for the CSD 200/300/400/500 DYNAMOMETER. Classified as Dynamometer, Ac-powered (product code LBB), Class II - Special Controls.

Submitted by John Chatillon & Sons, Inc. (Greensboro, US). The FDA issued a Cleared decision on February 15, 1994 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K931321

510(k) Number K931321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1993
Decision Date February 15, 1994
Days to Decision 336 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 149d · This submission: 336d
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 32
Devices cleared under the same product code (LBB) and FDA review panel - the closest regulatory comparables to K931321.
MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)
K964933 · Mekanika, Inc. · Feb 1997
DYNAMOMETER
K964685 · John Chatillon & Sons, Inc. · Jan 1997
GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM
K935757 · Greenleaf Medical Systems, Inc. · Apr 1994
NK GRASP SENSOR, MODEL GA001
K923964 · Nk Biotechnical Engineering Co. · May 1993
NK GRASP SENSOR, MODEL GA002
K923965 · Nk Biotechnical Engineering Co. · May 1993
NK DIGI-GRIP SENSOR, MODEL DGR001
K923963 · Nk Biotechnical Engineering Co. · Mar 1993
K931321 · CSD 200/300/400/500 DYNAMOMETER
Download PDF FDA Summary John Chatillon & Sons…