Cleared Traditional

K792248 - TAYLOR TRACTION CORD

K792248 is an FDA 510(k) clearance for TAYLOR TRACTION CORD, manufactured by Taylor Medical Equipment. The device is a Class 1 Neurology device with product code HST cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K792248 · Taylor Medical Equipment · Neurology device
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Nov 1979
Decision
23d
Days
Class 1
Risk

K792248 is an FDA 510(k) clearance for the TAYLOR TRACTION CORD. Classified as Apparatus, Traction, Non-powered (product code HST), Class I - General Controls.

Submitted by Taylor Medical Equipment (Mchenry, US). The FDA issued a Cleared decision on November 30, 1979 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.5850 - 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.

FDA 510(k) Submission Details - K792248

510(k) Number K792248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1979
Decision Date November 30, 1979
Days to Decision 23 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 149d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

HST Device Classification - Class 1, General Controls

Product Code HST Apparatus, Traction, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5850
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 - HST Apparatus, Traction, Non-powered

All 37
Devices cleared under the same product code (HST) and FDA review panel - the closest regulatory comparables to K792248.
UPPER EXTREMITY TRACTION DEVICE
K803021 · Orthopedic Systems, Inc. · Dec 1980
COTTRELL 90/90 BACKTRAC
K802555 · Lossing Orthopedic, Inc. · Oct 1980
PROT-A-TRAC
K802072 · Robert I. Branick, M.D. · Sep 1980
BAC JAC
K791919 · Haggin Industries, Inc. · Oct 1979
MEDI-TRAK PORTABLE TRACTION DEVICE
K791396 · Medicorp, Inc. · Aug 1979
OCTAGONAL ALUMINUM FRAMING SYSTEM
K790729 · Orthopedic Systems, Inc. · May 1979
K792248 · TAYLOR TRACTION CORD
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