Cleared Traditional

K791808 - CERVI-TRAC

K791808 is an FDA 510(k) clearance for CERVI-TRAC, manufactured by Dr. K.G. Rude. The device is a Class 1 Physical Medicine device with product code ILZ cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K791808 · Dr. K.G. Rude · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1979
Decision
20d
Days
Class 1
Risk

K791808 is an FDA 510(k) clearance for the CERVI-TRAC. Classified as Accessories, Traction (product code ILZ), Class I - General Controls.

Submitted by Dr. K.G. Rude (Mchenry, US). The FDA issued a Cleared decision on October 1, 1979 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5925 - 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.

FDA 510(k) Submission Details - K791808

510(k) Number K791808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1979
Decision Date October 01, 1979
Days to Decision 20 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 116d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

ILZ Device Classification - Class 1, General Controls

Product Code ILZ Accessories, Traction
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5925
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ILZ Accessories, Traction

All 14
Devices cleared under the same product code (ILZ) and FDA review panel - the closest regulatory comparables to K791808.
PELVIC TRACTION BELT
K823659 · Warm & Form, Orthopedic Materials · Dec 1982
PELVIC TRACTION BELT
K823166 · Warm & Form, Orthopedic Materials · Nov 1982
BOGER AUTO-TRACTION DEVICE
K820663 · D.C. Medical Device, Inc. · May 1982
BANDAGE SPREADER BLOCK
K780227 · Biomet, Inc. · Mar 1978
TRACTION BELT, PELVIC
K780234 · Biomet, Inc. · Feb 1978
SPREADER BARS
K780226 · Biomet, Inc. · Feb 1978
K791808 · CERVI-TRAC
Download PDF Dr. K.G. Rude