Cleared Traditional

K930021 - J TONGS

K930021 is an FDA 510(k) clearance for J TONGS, manufactured by Jerome Medical. The device is a Class 2 Neurology device with product code HAX cleared through the Traditional 510(k) pathway after a 1065-day FDA review.

K930021 · Jerome Medical · Neurology device
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Dec 1995
Decision
1065d
Days
Class 2
Risk

K930021 is an FDA 510(k) clearance for the J TONGS. Classified as Tong, Skull For Traction (product code HAX), Class II - Special Controls.

Submitted by Jerome Medical (Mt Laurel, US). The FDA issued a Cleared decision on December 6, 1995 after a review of 1065 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5960 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Jerome Medical devices

FDA 510(k) Submission Details - K930021

510(k) Number K930021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1993
Decision Date December 06, 1995
Days to Decision 1065 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
917d slower than avg
Panel avg: 148d · This submission: 1065d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAX Device Classification - Class 2, Special Controls

Product Code HAX Tong, Skull For Traction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5960
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 - HAX Tong, Skull For Traction

All 10
Devices cleared under the same product code (HAX) and FDA review panel - the closest regulatory comparables to K930021.
PMT HALO SYSTEM
K090733 · Pmt Corp. · Jul 2009
FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM
K980689 · Friddle'S Orthopedic Appliances, Inc. · Feb 1999
ACE CERVICAL TRACTION HALOZS, TONGS & PINS
K954069 · Ace Medical Co. · Oct 1995
NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE
K915530 · American Threshold Industries, Inc. · Aug 1992
PMT TRACTION TONGS
K871663 · Progress Mankind Technology · Jun 1987
MAYFIELD DISPOSABLE SKULL PINS
K853066 · Codman & Shurtleff, Inc. · Aug 1985